DALINGO 165 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Dalingo

Do not take Dalingo

If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

• 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 rash. If you experience any of these symptoms, you should see your doctor immediately.
• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with pregabalin treatment. Stop taking pregabalin and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
• Pregabalin, the active substance in this medicine, has been associated with dizziness and somnolence, which could increase the risk of accidental injury (falls) in elderly patients. Therefore, you should be cautious until you are familiar with the effects that the medicine can have.
• This medicine may cause blurred vision, loss of vision, or other changes in vision, many of which are transient. If you experience any changes in your vision, you should inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may need a change in their diabetes medications.
• Certain side effects, such as somnolence, may be more frequent as patients with spinal cord injury may be taking other medications for treatment, for example, pain or spasticity, with similar side effects to pregabalin, so the intensity of these effects may increase when taken together.
• There have been reports of heart failure in some patients treated with pregabalin. Most of them were elderly patients with cardiovascular diseases. Before using this medicine, you should tell your doctor if you have a history of heart disease.
• There have been reports of renal failure in some patients treated with pregabalin. If you notice a decrease in your ability to urinate during treatment with this medicine, you should inform your doctor, as stopping treatment may improve this situation.
• Some patients taking antiepileptics, such as pregabalin, have had thoughts of harming themselves or committing suicide or have shown suicidal behavior. If at any time you have these thoughts or have shown such behavior, you should contact your doctor as soon as possible.
• When this medicine is taken with other medicines that can cause constipation (such as some types of pain medications), gastrointestinal problems (such as constipation and intestinal blockage or paralysis) may occur. Inform your doctor if you suffer from constipation, especially if you are prone to this problem.
• Before taking this medicine, 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 medicine.
• There have been reports of seizures during treatment with pregabalin or shortly after stopping treatment. If you have seizures, you should contact your doctor immediately.
• There have been reports of reduced brain function (encephalopathy) in some patients taking pregabalin who had other diseases. You should tell your doctor if you have a history of any serious disease, including liver or kidney disease.
• There have been reports of breathing difficulties. If you have nervous system disorders, respiratory disorders, kidney failure, or are over 65 years old, your doctor may prescribe a different dose. You should contact your doctor if you experience breathing problems or shallow breathing.

Dependence

Some people may become dependent on pregabalin (need to continue taking the medicine). These people may experience withdrawal effects when they stop using this medicine (see section 3, "How to take Dalingo" and "If you stop taking Dalingo"). If you are concerned that you may become dependent on this medicine, you should 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 medicine for a longer period than recommended by your doctor.
• You feel that you need to take more of the recommended dose.
• You are using the medicine for reasons other than those prescribed.
• You have made repeated unsuccessful attempts to stop or control the use of the medicine.
• When you stop taking the medicine, you feel unwell and feel better once you take the medicine again.

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

Children and adolescents

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

Other medicines and Dalingo

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

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

• Oxycodone (used as a pain reliever)
• Lorazepam (used to treat anxiety)
• Alcohol

Pregabalin can be taken with oral contraceptives.

Taking Dalingo with food, drinks, and alcohol

It is advised not to drink alcohol during treatment with this medicine. For more information on treatment with pregabalin in relation to food, see section3, "How to take Dalingo".

Pregnancy and breastfeeding

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.

You should not take this medicine during pregnancy or breastfeeding, unless your doctor has told you to do so. The use of pregabalin during the first 3 months of pregnancy may cause congenital malformations in the fetus that require medical treatment. In a study that reviewed data from women in Nordic countries who took pregabalin in the first 3 months of pregnancy, 6 babies out of 100 had such congenital malformations. This compares with 4 babies out of 100 born to women not treated with pregabalin in the study. There have been reports of malformations of the face (orofacial clefts), eyes, nervous system (including the brain), kidneys, and genitals.

Women of childbearing age should use an effective method of contraception.

Driving and using machines

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 whether this medicine affects your ability to perform these activities.

3. How to take Dalingo

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Pregabalin is for oral use only. You should take pregabalin once a day, in the evening, immediately 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 properties.

Your doctor will determine the dose that is right for you.

• Take the number of tablets that your doctor has told you to take.
• The usual dose, which will have been adjusted for you and your condition, is between 165 mg and 660 mg per day.

If you think that the effect of pregabalin is too strong or too weak, talk to your doctor or pharmacist.

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

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

Continue taking pregabalin until your doctor tells you to stop.

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

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

• take your dose of immediate-release pregabalin in the morning as prescribed
• then start taking pregabalin after dinner

Do not switch medicines unless your doctor has told you to do so. He will also tell you the right dose for your condition.

If you have any questions or doubts, you should ask your doctor.

If you take more Dalingo than you should

Call your doctor or go to the nearest emergency room immediately. Take the pack 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. There have also been reports of seizures and unconsciousness (coma).

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

If you forget to take Dalingo

It is important that you take the pregabalin tablets regularly at the same time every day. If you forget to take a dose, take it as soon as you remember, always after eating, unless it is time for your next dose. In that case, continue with your next dose as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking 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 stop treatment, it should be done gradually over a minimum of one week. Once you have finished short-term or long-term treatment with pregabalin, you should know that you may experience certain side effects, called withdrawal effects. These effects include sleep problems, headache, nausea, feeling anxious, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of harming yourself or committing suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking pregabalin for a longer period. If you experience withdrawal effects, you should see your doctor.

If you have any doubts 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 all people suffer from 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.
• Feeling of euphoria, confusion, disorientation, decreased sexual appetite, irritability.
• Attention alteration, movement clumsiness, memory impairment, memory loss, tremors, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhea, nausea, bloated abdomen.
• Difficulty getting an erection.
• Swelling of the body including the limbs.
• Feeling of drunkenness, gait disturbances.
• Weight gain
• Muscle cramp, joint pain, back pain, limb pain.
• Sore throat.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Change in self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, anxiety attacks, apathy, aggression, elevated mood, mental impairment, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation.
• Changes in vision, unusual eye movements, changes in vision including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness when standing up, sensitive skin, loss of taste, burning sensation, tremor when moving, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, eye swelling, eye pain, tired eyes, teary eyes, eye irritation.
• Heart rhythm disturbances, 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, heartburn, 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 when urinating, inability to hold urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated creatine phosphokinase in blood, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine in blood, decreased potassium in blood).
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring.
• Painful menstrual periods.
• Feeling of cold in hands and feet.

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

• Altered sense of smell, oscillating vision, depth perception alteration, visual glare, loss of vision.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Pancreatitis.
• Difficulty swallowing.
• Slow or reduced body mobility.
• Difficulty writing correctly.
• Increased fluid in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disturbances.
• Muscle damage.
• Milk secretion, abnormal breast growth, increased breast size in men.
• Menstrual period interruption.
• Kidney failure, reduced urine output, urine 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 reddish, non-raised, circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, symptoms similar to Parkinson's disease, such as tremors, bradykinesia (decreased ability to move), and muscle stiffness.

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

• Liver failure.
• Hepatitis (liver inflammation).

Frequency Not Known: cannot be estimated from the available data

• Becoming dependent on pregabalin ('drug dependence').

Once you have finished a short or long-term treatment with this medicine, you should know that you may experience certain adverse effects, called withdrawal effects (see "If you stop treatment with Dalingo").

If you experience swelling in the face or tongue, or if your skin turns red and has blisters or peeling, you should seek medical attention immediately.

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

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this 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. Storage of Dalingo

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

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

For 82.5 mg:Do not store above 30 °C.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection 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 of Dalingo

The active ingredient is pregabalin.

Dalingo 82.5 mg prolonged-release tablets

Each prolonged-release tablet contains 82.5 mg of pregabalin.

Dalingo 165 mg prolonged-release tablets

Each prolonged-release tablet contains 165 mg of pregabalin.

Dalingo 330 mg prolonged-release tablets

Each prolonged-release tablet contains 330 mg of pregabalin.

The other ingredients are:

• Tablet content: hypromellose, hydroxypropylcellulose (E 463), butyl methacrylate basic copolymer (E 1205), crospovidone (type A), magnesium stearate (E 470b), anhydrous colloidal silica (E 551).
• Coating material: poly (vinyl alcohol) (E 1203), titanium dioxide (E 171), macrogol (E 1521), and talc (E 553b).

Dalingo 165 mg prolonged-release tablets

also contain yellow iron oxide (E 172) and red iron oxide (E 172).

Dalingo 330 mg prolonged-release tablets

also contain red iron oxide (E 172) and black iron oxide (E 172).

• Printing ink: shellac, black iron oxide (E 172), propylene glycol (E 1520)

Appearance of the Product and Package Contents

Dalingo 82.5 mg prolonged-release tablets

White, oval, uncoated tablet, without inscription on one side and with the inscription "ALV 379" printed in black ink on the other side, with 19 mm in length, 12 mm in width, and approximately 7 mm in thickness.

Dalingo 165 mg prolonged-release tablets

Yellow, oval, uncoated tablet, without inscription on one side and with the inscription "ALV 380" printed in black ink on the other side, with 19 mm in length, 12 mm in width, and approximately 7 mm in thickness.

Dalingo 330 mg prolonged-release tablets

Pink, oval, uncoated tablet, without inscription on one side and with the inscription "ALV 381" printed in black ink on the other side, with 19 mm in length, 12 mm in width, and approximately 8 mm in thickness.

Dalingo is available in:

• Cardboard box containing a round, white, wide-mouthed HDPE bottle with a child-resistant closure and a desiccant cylinder.
• Original packaging with 30 prolonged-release tablets.

Multipack packaging with 90 (3 x 30) prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Gebro Pharma S.A.

Avenida Tibidao, 29

08022 Barcelona

Spain

Manufacturer:

Kevaro Group Ltd

9 Tzaritza Elenora Str., Office 23

Sofia, 1618

Bulgaria

This medicine is authorized in the Member States of the European Economic Area under 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 tabletten met verlengde afgifte

Dalingo 165 mg tabletten met verlengde afgifte

Dalingo 330 mg tabletten met verlengde afgifte

Date of the Last Revision of this Prospectus: September 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/