Leaflet: information for the user

Dalingo 82.5mg prolonged-release tablets

Dalingo 165mg prolonged-release tablets

Dalingo 330mg prolonged-release tablets

pregabalin

Read 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 others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What Dalingo is and what it is used for

2.What you need to know before you start taking Dalingo

3.How to take Dalingo

4.Possible side effects

5.Storage of Dalingo

6.Contents of the pack and additional information

Dalingo belongs to a group of medications used for the treatment of neuropathic pain in adults.

Pregabalin is used for the treatment of chronic pain caused by nerve damage. There are various diseases that can cause peripheral neuropathic pain, such as diabetes or herpes. The sensation of pain could be described as heat, burning, pulsating pain, stabbing pain, sharp pain, acute pain, cramps, continuous pain, tingling, numbness, and a sensation of pins and needles. Peripheral and central neuropathic pain could also be associated with changes in mood, sleep disturbances, fatigue (tiredness), and can affect physical and social activity and overall quality of life.

Do not take Dalingo

If you are allergic to pregabalin or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

-Some patients treated with pregabalin have reported symptoms that suggest an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as the appearance of a diffuse skin rash. If you experience any of these symptoms, you should seek immediate medical attention.

-Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section4.

-Pregabalin, the active ingredient in this medication, has been associated with dizziness and somnolence, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects of the medication.

-This medication may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any alteration in your vision, you should inform your doctor immediately.

-Patients with diabetes who gain weight while taking pregabalin may need to change their diabetes medications.

-Certain adverse effects, such as somnolence, may be more frequent since patients with spinal cord injury may be taking other medications for treatment, for example, pain or spasticity, with adverse effects similar to those of pregabalin, so the intensity of these effects may increase when taken together.

-Severe heart failure has been reported in some patients treated with pregabalin. Most of them were elderly patients with cardiovascular diseases.Before using this medication, you should inform your doctor if you have a history of heart disease.

-Severe kidney failure has been reported in some patients treated with pregabalin. If during treatment with this medication you note a decrease in your ability to urinate, you should inform your doctor since stopping treatment may improve this situation.

-Some patients taking antiepileptic medications such as pregabalin have had thoughts of self-harm or suicide or have shown suicidal behavior. If at any time you experience these thoughts or have shown such behavior, contact your doctor as soon as possible.

-When this medication is taken with other medications that can cause constipation (such as some types of pain medications), it is possible that gastrointestinal problems (such as constipation and intestinal blockage or paralysis) may occur. Inform your doctor if you experience constipation, especially if you are prone to this problem.

-Before taking this medication, inform your doctor if you have ever abused or been dependent on alcohol, prescription medications, or illegal drugs; this may mean that you have a higher risk of becoming dependent on this medication.

-Severe seizures have been reported during treatment with pregabalin or shortly after stopping treatment. If you experience seizures, contact your doctor immediately.

-Severe brain dysfunction (encephalopathy) has been reported in some patients taking pregabalin and having other serious diseases. Inform your doctor if you have a history of any serious disease, including liver or kidney disease.

-Severe breathing difficulties have been reported. If you have nervous system disorders, respiratory disorders, kidney failure, or are over 65 years old, your doctor may prescribe a different dose. Contact your doctor if you experience breathing problems or shallow breathing.

Dependence

Some people may become dependent on pregabalin (need to continue taking the medication). These people may experience withdrawal effects when they stop using this medication (see section 3, “How to take Dalingo” and “If you stop taking Dalingo”). If you are concerned that you may become dependent on this medication, it is essential to consult your doctor.

If you notice any of the following signs while taking pregabalin, it could be a sign that you have become dependent:

-You need to take the medication for a longer time than recommended by your doctor.

-You feel the need to take a higher dose than recommended.

-You are using the medication for reasons other than those prescribed.

-You have made repeated and unsuccessful attempts to stop or control the use of the medication.

-When you stop taking the medication, you feel unwell and feel better once you take the medication again.

If you notice any of these signs, talk to your doctor to analyze the best plan of care for you, including when it is appropriate to stop treatment and how to do it safely.

Children and adolescents

The safety and efficacy have not been established in children and adolescents (under 18 years), so pregabalin should not be used in this age group.

Other medications and Dalingo

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

Pregabalin and certain medications may interact with each other (interactions). When pregabalin is used with certain medications that have a sedative effect (including opioids), these effects may be potentiated and may lead to respiratory failure, coma, and death. The degree of dizziness, somnolence, and decreased concentration may increase if pregabalin is taken with other medications that contain:

•Oxycodone (used as an analgesic)

•Lorazepam (used to treat anxiety)

•Alcohol

Pregabalin can be taken with oral contraceptives.

Taking Dalingo with food, drinks, and alcohol

It is recommended not to take alcohol during treatment with this medication. For more information on pregabalin treatment in relation to food,see section3, “How to take Dalingo”.

Pregnancy and breastfeeding

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

You should not take this medication during pregnancy or breastfeeding, unless your doctor has told you to. Pregabalin use during the first 3 months of pregnancy may cause congenital anomalies in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of 100 babies had such congenital anomalies. This contrasts with 4 out of 100 babies born to women not treated with pregabalin in the study. Facial abnormalities (cleft palate), eye abnormalities, nervous system abnormalities (including the brain), kidney abnormalities, and genital abnormalities have been reported.

Women of childbearing age should use an effective contraceptive method.

Driving and operating machinery

Pregabalin may cause dizziness, somnolence, and decreased concentration. You should not drive, operate heavy machinery, or engage in other potentially hazardous activities until you know if this medication affects your ability to perform these activities.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Pregabalin is exclusively for oral use. You should take pregabalin once a day, in the evening, just after dinner. Swallow the tablet whole with water. Do not break, crush, or chew the tablet. The tablet should not be broken because this could affect its characteristics.

Your doctor will determine what dose is suitable for you.

-Take the number of tablets that your doctor has indicated.

-The usual dose, which will have been adjusted for you and your condition, is between 165mg and 660mg per day.

If you estimate that the action of pregabalin is too strong or too weak, inform your doctor or pharmacist.

If you are an elderly patient (over 65 years old), you should take this medication normally, except if you have kidney problems.

Your doctor may prescribe another dosing regimen and/or different doses if you have kidney problems.

Continue taking pregabalin until your doctor tells you to stop.

Switching from pregabalin immediate-release to pregabalin prolonged-release, such as this medication:

When switching from pregabalin immediate-release to pregabalin prolonged-release, such as this medication, your doctor will explain how to do it. They will instruct you to follow these steps:

-take your pregabalin immediate-release dose in the morning as prescribed

-then start taking pregabalin after dinner

Do not change medication unless your doctor has instructed you to. They will also indicate the suitable dose for your condition.

If you have doubts or questions, consult your doctor.

If you take more Dalingo than you should

Call your doctor or go to the nearest emergency service immediately. Bring the box or container (bottle) of pregabalin tablets with you. As a result of taking more pregabalin than you should, you may feel drowsy, confused, agitated, or restless. Seizures and loss of consciousness (coma) have also been reported.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dalingo

It is essential to take the pregabalin tablets regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, always after eating, unless it is time for the next dose. In that case, continue with the next dose normally. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dalingo

Do not stop taking pregabalin suddenly. If you want to stop taking pregabalin, talk to your doctor first. Your doctor will tell you how to do it. If you are going to suspend treatment, this should be done gradually over a minimum of one week. Once the treatment with pregabalin is completed, either short-term or long-term, you should know that you may experience certain adverse effects, called withdrawal effects. These effects include insomnia, headaches, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may appear more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, consult your doctor.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

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

Very common: may affect more than 1 in 10 people

Dizziness, drowsiness, headache.

Common: may affect up to 1 in 10 people

-Increased appetite.

-Euphoria, confusion, disorientation, decreased sexual desire, irritability.

-Disturbance of attention, clumsiness of movement, deterioration of memory, loss of memory, tremors, difficulty speaking, sensation of tingling, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.

-Blurred vision, double vision.

-Dizziness, balance problems, falls.

-Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, swollen abdomen.

-Difficulty with erection.

-Swelling of the body including extremities.

-Sensation of intoxication, alterations of gait.

-Weight gain

-Muscle cramps, joint pain, back pain, pain in extremities.

-Throat pain.

Uncommon: may affect up to 1 in 100 people

-Loss of appetite, weight loss, low blood sugar, high blood sugar.

-Change in self-perception, anxiety, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual desire, sexual dysfunction including inability to reach climax, delayed ejaculation.

-Changes in vision, abnormal eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, decreased reflexes, hyperactivity, dizziness when standing, sensitive skin, loss of taste, burning sensation, tremors when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to sounds, general discomfort.

-Eye dryness, eye swelling, eye pain, tired eyes, watery eyes, eye irritation.

-Changes in heart rhythm, increased heart rate, low blood pressure, high blood pressure, changes in heart rhythm, heart failure.

-Flushing, hot flashes.

-Difficulty breathing, dry nose, nasal congestion.

-Increased saliva production, burning sensation, numbness around the mouth.

-Sweating, rash, chills, fever.

-Muscle spasms, joint swelling, muscle stiffness, pain including muscle pain, neck pain.

-Breast pain.

-Difficulty or pain urinating, inability to hold urine.

-Weakness, thirst, chest oppression.

-Changes in blood test results and liver function tests (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, elevated creatinine in blood, decreased potassium in blood).

-Hypersensitivity, facial swelling, itching, urticaria, runny nose, nasal bleeding, cough, snoring.

-Painful menstruation.

-Sensation of cold in hands and feet.

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

-Altered sense of smell, oscillating vision, altered perception of depth, visual brightness, loss of vision.

-Dilated pupils, strabismus.

-Cold sweat, throat oppression, tongue swelling.

-Pancreatitis.

-Difficulty swallowing.

-Reduced mobility of the body.

-Difficulty writing correctly.

-Fluid accumulation in the abdominal area.

-Fluid in the lungs.

-Seizures.

-Changes in electrocardiogram (ECG) corresponding to heart rhythm alterations.

-Muscle damage.

-Milk secretion, abnormal breast growth, increased breast size in men.

-Menstrual interruption.

-Renal insufficiency, reduced urine output, urinary retention.

-Decreased white blood cell count.

-Inappropriate behavior, suicidal behavior, suicidal thoughts.

-Allergic reactions that may include difficulty breathing, eye inflammation (keratitis) and a severe skin reaction characterized by red patches, often with central blisters, peeling skin, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

-Icterus (yellow skin and eyes).

-Parkinsonism, Parkinson-like symptoms, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

Very rare: may affect up to 1 in 10,000 people

-Liver insufficiency.

-Hepatitis (liver inflammation).

Frequency not known: cannot be estimated from available data

-Becoming dependent on pregabalin (‘drug dependence’).

Once a short or long-term treatment with this medicine has been completed, you should know that you may experience certain side effects, called withdrawal effects (see “If you stop treatment with Dalingo”).

If you experience swelling in the face or tongue, or if your skin becomes red and blistered or peels, you should seek immediate medical attention.

Certain side effects, such as drowsiness, may be more frequent since patients with spinal cord injury may be taking other medications to treat, for example, pain or spasticity, with side effects similar to those of pregabalin, so the intensity of these side effects may increase when these medications are taken together.

The following adverse reaction has been reported in post-marketing experience: difficulty breathing, shallow breathing.

Reporting of adverse reactions

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box or on the container (bottle). The expiration date is the last day of the month indicated.

For 82.5mg:Do not store at a temperature above 30?°C.

For 165mg and 330mg:This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Dalingo

The active ingredient is pregabalin.

Dalingo 82.5mg prolonged-release tablets

Each prolonged-release tablet contains 82.5mg of pregabalin.

Dalingo 165mg prolonged-release tablets

Each prolonged-release tablet contains 165mg of pregabalin.

Dalingo 330mg prolonged-release tablets

Each prolonged-release tablet contains 330mg of pregabalin.

The other components are:

•Tablet core:hypromellose, hydroxypropylcellulose (E 463), basic butyl methacrylate copolymer (E 1205), crospovidone (type A), magnesium stearate (E 470b), anhydrous colloidal silica (E 551).

•Capsule coating:polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol (E 1521) and talc (E 553b).

Dalingo 165mg prolonged-release tablets

also contains yellow iron oxide (E172) and red iron oxide (E 172).

Dalingo 330mg prolonged-release tablets

also contains red iron oxide (E172) and black iron oxide (E 172).

•Printing ink:shellac, black iron oxide (E 172), propylene glycol (E1520)

Appearance of the product and contents of the package

Dalingo 82.5mg prolonged-release tablets

White, oval, unnotched, uncoated tablet, without inscription on one side and with the inscription “ALV379” printed in black ink on the other side, with 19mm in length, 12mm in width and approximately 7mm in thickness.

Dalingo 165mg prolonged-release tablets

Yellow, oval, unnotched, uncoated tablet, without inscription on one side and with the inscription “ALV380” printed in black ink on the other side, with 19mm in length, 12mm in width and approximately 7mm in thickness.

Dalingo 330mg prolonged-release tablets

Pink, oval, unnotched, uncoated tablet, without inscription on one side and with the inscription “ALV381” printed in black ink on the other side, with 19mm in length, 12mm in width and approximately 8mm in thickness.

Dalingo is available in:

-Carton box containing a HDPE round bottle with a wide mouth, white child-resistant cap with a coating and a desiccant cylinder.

-Original packaging with 30prolonged-release tablets.

Multi-pack packaging with 90 (3x30) prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Laboratorios Gebro Pharma S.A.

Avenida Tibidao, 29

08022 Barcelona

Spain

Manufacturer responsible:

Kevaro Group Ltd

9 Tzaritza Elenora Str., Office 23

Sofia, 1618

Bulgaria

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Spain – Dalingo 82.5 mg prolonged-release tablets

Dalingo 165 mg prolonged-release tablets

Dalingo 330 mg prolonged-release tablets

Netherlands – Dalingo 82.5 mg prolonged-release tablets

Dalingo 165 mg prolonged-release tablets

Dalingo 330 mg prolonged-release tablets

Last review date of this leaflet: September 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/