Dalingo 165 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dalingo 82.5mg prolonged-release tablets

Dalingo 165mg prolonged-release tablets

Dalingo 330mg prolonged-release tablets

pregabalin

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

1. What Dalingo is and what it is used for

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

Pregabalin is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes. The pain sensation may be described as heat, burning, throbbing pain, shooting pain, stabbing pain, sharp pain, cramps, continuous pain, tingling, numbness, and pins-and-needles sensations. Peripheral and central neuropathic pain may also be associated with changes in mood, sleep disturbances, fatigue (tiredness), and may affect physical and social activity and overall quality of life.

2. What you need to know before taking Dalingo

Do not take Dalingo

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

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• Some patients treated with pregabalin have reported symptoms indicating an allergic reaction. These symptoms include swelling of the face, lips, tongue, and throat, as well as development of widespread skin rash. If you experience any of these symptoms, you must seek immediate medical attention.
• Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking pregabalin and seek immediate medical help if you notice any symptoms related to these serious skin reactions described in section 4.
• Pregabalin, the active substance in this medicine, has been associated with dizziness and drowsiness, which could increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with the effects this medicine may have.
• This medicine may cause blurred vision, vision loss, or other changes in eyesight, many of which are temporary. If you experience any changes in your vision, you must inform your doctor immediately.
• Diabetic patients who gain weight while taking pregabalin may require adjustments in their diabetes medications.
• Certain adverse effects, such as drowsiness, may be more common in patients with spinal cord injury, as they may be taking other medications for conditions such as pain or spasticity, which have similar side effects to pregabalin, thereby increasing the intensity of these effects when taken together.
• Cases of heart failure have been reported in some patients treated with pregabalin. Most of these patients were elderly with pre-existing cardiovascular diseases. Before using this medicine, you must inform your doctor if you have a history of heart disease.
• Cases of renal failure have been reported in some patients treated with pregabalin. If during treatment with this medicine you notice a decrease in your ability to urinate, inform your doctor, as discontinuation of treatment may improve this condition.
• Some patients receiving antiepileptic medicines such as pregabalin have experienced thoughts of self-harm or suicide, or have exhibited suicidal behavior. If at any time you experience such thoughts or behaviors, contact your doctor as soon as possible.
• When this medicine is taken together with other medicines that may cause constipation (such as certain types of pain medications), 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 medicine, inform your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or illegal drugs; this may mean you have a higher risk of becoming dependent on this medicine.
• Seizures have been reported during treatment with pregabalin or shortly after discontinuation. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have been reported in some patients taking pregabalin who also had other medical conditions. Inform your doctor if you have a history of serious illness, including liver or kidney disease.
• Cases of difficulty breathing have been reported. If you have disorders of the nervous system, respiratory disorders, renal failure, or are over 65 years of age, your doctor may prescribe a different dose. Contact your doctor if you experience breathing difficulties or shallow breathing.

Dependence

Some people may become dependent on pregabalin (a need to keep taking the medicine). These individuals may experience withdrawal symptoms when they stop using the medicine (see section 3, “How to take Dalingo” and “If you stop taking Dalingo”). If you are concerned about becoming dependent on this medicine, it is important to consult your doctor.

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

• You need to take the medicine for longer than recommended by your doctor.
• You feel the need to take more than 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 it again.

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

Children and adolescents

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

Other medicines and Dalingo

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

Pregabalin and certain medicines may affect each other (interactions). When pregabalin is used together with certain medicines that have a sedative effect (including opioids), these effects may be enhanced and may lead to respiratory failure, coma, and death. The degree of dizziness, drowsiness, and reduced concentration may increase if pregabalin is taken together with medicines containing:

• 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

You are advised not to drink alcohol during treatment with this medicine. For more information about pregabalin treatment in relation to food, see section 3, “How to take Dalingo”.

Pregnancy and breastfeeding

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

You should not take this medicine during pregnancy or breastfeeding unless your doctor has specifically instructed 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 reviewing data from women in Nordic countries who took pregabalin during the first 3 months of pregnancy, 6 out of every 100 babies had such congenital malformations. This compares with 4 out of every 100 babies born to women not treated with pregabalin in the study. Malformations reported include those of the face (cleft lip/palate), eyes, nervous system (including the brain), kidneys, and genitals.

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

Driving and using machines

Pregabalin may cause dizziness, drowsiness, and reduced concentration. You should not drive, operate heavy machinery, or engage in other potentially dangerous activities until you know whether this medicine affects your ability to perform these activities.

3. How to take Dalingo

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

Pregabalin is for oral use only. You should take pregabalin once daily, at night, just after dinner. Swallow the tablet whole with water. Do not break, crush, or chew the tablet. The tablet must not be broken, as this could affect its characteristics.

Your doctor will determine the appropriate dose for you.

• Take the number of tablets your doctor has prescribed.
• The usual dose, adjusted according to your condition, ranges between 165 mg and 660 mg per day.

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

If you are an elderly patient (over 65 years of age), you should take this medicine as usual, 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 medicines, 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 and will instruct 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 medications unless your doctor has instructed you to do so. Your doctor will also indicate the appropriate dose for your condition.

If you have any doubts or questions, consult your doctor.

If you take more Dalingo than you should

Call your doctor or go to the nearest emergency department immediately. Take 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dalingo

It is important that you take pregabalin tablets regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, but only after eating, unless it is almost 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 a missed dose.

If you stop taking Dalingo

Do not stop taking pregabalin suddenly. If you wish to stop taking pregabalin, speak to your doctor first. Your doctor will tell you how to do it. If you discontinue treatment, this should be done gradually over a minimum of one week. After short- or long-term treatment with pregabalin, you should be aware that you may experience certain adverse effects, known as withdrawal effects. These effects include sleep problems, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, sweating, and dizziness. These effects may occur more frequently or severely if you have been taking pregabalin for a longer period of time. If you experience withdrawal effects, you should contact your doctor.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common: may affect more than 1 in 10 people

Dizziness, somnolence, headache.

Common: may affect up to 1 in 10 people

• Increased appetite.
• Feeling of euphoria, confusion, disorientation, decreased sexual drive, irritability.
• Attention disturbance, clumsiness of movement, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensation.
• Blurred vision, double vision.
• Dizziness, balance problems, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, bloated abdomen.
• Difficulty in erection.
• Swelling of the body including limbs.
• Feeling of drunkenness, disturbances in gait.
• 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.
• Altered self-perception, restlessness, depression, agitation, mood changes, difficulty finding words, hallucinations, strange dreams, panic attacks, apathy, aggression, elevated mood, mental deterioration, difficulty thinking, increased sexual appetite, sexual relationship problems including inability to reach climax, delayed ejaculation.
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, flashes of light, spasmodic movements, reduced reflexes, hyperactivity, dizziness upon standing, sensitive skin, loss of taste, burning sensation, movement-related tremor, decreased consciousness, loss of consciousness, fainting, increased sensitivity to noise, general malaise.
• Dry eyes, 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 flushes.
• Difficulty breathing, nasal dryness, 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 when urinating, inability to control urine.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (elevated blood creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, decreased platelet count, neutropenia, increased blood creatinine, decreased blood potassium).
• Hypersensitivity, facial swelling, itching, urticaria, 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 disturbance, visual glare, vision loss.
• Dilated pupils, strabismus.
• Cold sweat, throat tightness, tongue swelling.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slow or reduced body mobility.
• Difficulty writing properly.
• Increased fluid in the abdominal area.
• Fluid in the lungs.
• Seizures.
• Changes in electrocardiogram (ECG) corresponding to heart rhythm disturbances.
• Muscle damage.
• Milk secretion, abnormal breast growth, breast enlargement in men.
• Interruption of menstrual periods.
• Kidney failure, reduced urine output, urine retention.
• Decreased white blood cell count.
• Inappropriate behaviour, suicidal behaviour, suicidal thoughts.
• Allergic reactions which may include difficulty breathing, eye inflammation (keratitis), and a severe skin reaction characterised by flat, non-elevated, circular or coin-shaped red patches on the chest, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes).
• Parkinsonism, Parkinson's disease-like symptoms such as tremor, bradykinesia (reduced ability to move), and muscle rigidity.

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

• Liver failure.
• Hepatitis (inflammation of the liver).

Frequency not known: cannot be estimated from available data

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

After stopping short- or long-term treatment with this medicine, you should be aware that you may experience certain adverse effects, known as withdrawal effects (see "If you stop taking Dalingo").

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

Certain adverse effects, such as somnolence, may be more frequent because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have adverse effects similar 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 adverse effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can 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 Dalingo

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or container (bottle). The expiry date refers to the last day of the month indicated.

HDPE bottle:

For 82.5 mg: Do not store above 30 °C.

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

Blister:

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Dalingo

The active substance 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 components are:

• Tablet core: hypromellose, hydroxypropylcellulose (E 463), basic butyl methacrylate copolymer (E 1205), crospovidone (type A), magnesium stearate (E 470b), colloidal anhydrous 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-shaped, unmarked on one side and printed with "ALV 379" in black ink on the other side, 19 mm long, 12 mm wide and approximately 7 mm thick.

Dalingo 165 mg prolonged-release tablets

Yellow, oval-shaped, unmarked on one side and printed with "ALV 380" in black ink on the other side, 19 mm long, 12 mm wide and approximately 7 mm thick.

Dalingo 330 mg prolonged-release tablets

Pink, oval-shaped, unmarked on one side and printed with "ALV 381" in black ink on the other side, 19 mm long, 12 mm wide and approximately 8 mm thick.

Dalingo is available in a round, white, wide-mouth HDPE bottle with a white child-resistant cap with liner and a desiccant cylinder, containing 30 prolonged-release tablets, and in a multipack pack containing 90 (3 x 30) prolonged-release tablets.

Additionally, Dalingo is available in aluminium-polyamide/aluminium/PVC blisters, in a pack containing 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 medicinal product is authorized in the European Economic Area member states 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 most recent review of this leaflet: September 2024

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