Pregamid

Leaflet included in the packaging: patient information

Pregamid, 25 mg, hard capsules
Pregamid, 50 mg, hard capsules
Pregamid, 75 mg, hard capsules
Pregamid, 150 mg, hard capsules
Pregabalin
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pregamid and what is it used for
• 2. Important information before taking Pregamid
• 3. How to take Pregamid
• 4. Possible side effects
• 5. How to store Pregamid
• 6. Contents of the packaging and other information

1. What is Pregamid and what is it used for

Pregamid belongs to a group of medicines used to treat epilepsy, neuropathic pain, and generalized anxiety disorder in adults.
Neuropathic pain of peripheral and central origin: Pregamid is used to treat long-term pain caused by nerve damage. Neuropathic pain (of peripheral origin) can be caused by many diseases, such as diabetes or shingles. The pain can be described as a feeling of heat, burning, throbbing, stabbing, shooting, sharp, cramping, tingling, or numbness. Peripheral and central neuropathic pain can also be accompanied by mood changes, sleep disturbances, fatigue, which can affect the patient's physical and social functioning and overall quality of life.
Epilepsy:Pregamid is used to treat certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Pregamid if your current treatment does not fully control your condition. Pregamid should always be used as an add-on therapy to your current treatment. Pregamid should not be used as monotherapy, but always in combination with other antiepileptic medicines.
Generalized anxiety disorder:Pregamid is used to treat generalized anxiety disorder (GAD). The symptoms of GAD include prolonged, excessive anxiety and worry that is difficult to control. GAD can also cause restlessness, feeling on edge, or irritability, easy fatigue, difficulty concentrating or feeling empty in the head, irritability, increased muscle tension, or sleep disturbances. The symptoms are different from the stresses and strains of everyday life.

2. Important information before taking Pregamid

When not to take Pregamid

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

Warnings and precautions

Before taking Pregamid, you should discuss it with your doctor or pharmacist.

• Some patients taking Pregamid have experienced symptoms suggesting allergic reactions. These symptoms include swelling of the face, lips, tongue, and throat, as well as a rash. If you experience any of these symptoms, you should contact your doctor immediately.
• The use of Pregamid has been associated with dizziness and drowsiness, which can increase the frequency of accidental injuries (falls) in elderly patients. Therefore, you should be cautious until you know how the medicine affects you.
• Pregamid may cause blurred vision, loss of vision, or other vision disturbances, most of which are temporary. You should contact your doctor immediately if you experience any vision disturbances.
• In some patients with diabetes, who have gained weight while taking pregabalin, it may be necessary to adjust their antidiabetic treatment.
• Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin. The severity of these side effects may also be greater if these medicines are taken at the same time.
• There have been reports of heart failure in some patients taking Pregamid; most of them were elderly patients with cardiovascular disorders.

Before taking this medicine, you should inform your doctor about any history of heart disease.

• There have been reports of kidney failure in some patients taking Pregamid. If you experience a decrease in urine output while taking Pregamid, you should consult your doctor, as stopping the medicine may cause the symptom to disappear.
• A small number of patients taking antiepileptic medicines, such as Pregamid, have had thoughts of self-harm or suicidal thoughts. If you experience such thoughts, you should contact your doctor immediately.
• When taking Pregamid with other medicines that can cause constipation (e.g., certain painkillers), gastrointestinal disturbances (e.g., constipation, ileus, or intestinal obstruction) may occur. You should contact your doctor if you experience constipation, especially if you have a history of such disturbances.
• Before taking this medicine, you should inform your doctor if you have a history of alcohol abuse or have been addicted to or abused medicines. You should not take a higher dose of the medicine than recommended by your doctor.
• There have been reports of seizures during treatment with Pregamid or shortly after stopping treatment. If you experience seizures, you should contact your doctor immediately.
• There have been reports of decreased brain activity (encephalopathy) in some patients taking Pregamid, who have had other diseases. You should inform your doctor about all serious diseases you have had in the past, including liver and kidney diseases.
• There have been reports of breathing difficulties. If you experience neurological disturbances, breathing difficulties, kidney disturbances, or are over 65 years old, your doctor may recommend a different dosing schedule. If you experience breathing difficulties or shallow breathing, you should contact your doctor.
• Pregabalin has been associated with the occurrence of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. If you experience any of the symptoms of severe skin reactions mentioned in section 4, you should stop taking pregabalin and seek medical attention immediately.

Children and adolescents

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

Pregamid and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregamid and some other medicines may affect each other's activity (interactions). Pregamid taken with other medicines that have a sedating effect (including opioids) may increase this effect and lead to respiratory failure, drowsiness, and death. The severity of dizziness, drowsiness, and decreased concentration may be greater if Pregamid is taken with medicines containing:

• oxycodone (used as a painkiller),
• lorazepam (used to treat anxiety),
• alcohol.

Pregamid can be taken with oral contraceptives.

Pregamid with food and alcohol

Pregamid can be taken with or without food.
It is recommended that you do not drink alcohol while taking Pregamid.

Pregnancy, breastfeeding, and fertility

Pregamid should not be taken during pregnancy or breastfeeding, unless your doctor decides otherwise. Women of childbearing age must use effective contraception.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Pregamid may cause dizziness, drowsiness, and decreased concentration. You should not drive, operate machinery, or perform other potentially hazardous activities until you know how the medicine affects you.

Pregamid contains lactose

If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Pregamid

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
Your doctor will determine the dose of the medicine that is right for you.
Pregamid is for oral use only.

Neuropathic pain of peripheral and central origin, epilepsy, or generalized anxiety disorder:

• You should take the number of capsules that your doctor has prescribed for you.
• The dose will usually be between 150 mg and 600 mg per day.
• Your doctor will tell you to take Pregamid either twice or three times a day. If you take it twice a day, you should take it in the morning and evening, at about the same time every day. If you take it three times a day, you should take it in the morning, afternoon, and evening, at about the same time every day.

If you feel that the effect of Pregamid is too strong or too weak, you should consult your doctor or pharmacist.
In elderly patients (over 65 years of age), the recommended dose should be taken, unless you have kidney disease.
If you have kidney problems, your doctor may prescribe a different dosing schedule and/or dose.
The capsules should be swallowed whole with water.
You should take the medicine for as long as your doctor tells you to.

Taking a higher dose of Pregamid than recommended

You should contact your doctor or go to the emergency department of the nearest hospital immediately. You should take the packaging of Pregamid with you.
After taking a higher dose than recommended, you may feel drowsy, confused, agitated, or restless. There have also been reports of seizures.

Missing a dose of Pregamid

It is important to take Pregamid regularly, at the same time every day. If you miss a dose, you should take it as soon as possible, unless it is almost time for your next dose. In this case, you should continue treatment as scheduled. You should not take a double dose to make up for the missed dose.

Stopping treatment with Pregamid

You should not stop taking Pregamid unless your doctor tells you to. Stopping treatment should be done gradually over at least 1 week.
You should be aware that after stopping both short-term and long-term treatment with Pregamid, side effects may occur. These include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, thoughts of self-harm or suicide, pain, excessive sweating, and dizziness. These symptoms may occur more frequently or be more severe if you have taken Pregamid for a long time.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pregamid can cause side effects, although not everybody gets them.

Very common – may affect more than 1 in 10 people:

• Dizziness of central origin, drowsiness, headache

Common – may affect up to 1 in 10 people:

• Increased appetite
• Feeling of euphoria, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremors, speech disturbances, numbness, sedation, lethargy, insomnia, fatigue, abnormal sensations
• Blurred vision, double vision
• Dizziness of vestibular origin, balance disturbances, falls
• Dryness of the mucous membranes of the mouth, constipation, vomiting, bloating, diarrhea, nausea, feeling of abdominal distension
• Erectile dysfunction
• Body swelling, including weight gain
• Muscle spasms, 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, high blood sugar
• Changes in self-perception, restlessness, depression, agitation, mood changes, difficulty finding the right words, hallucinations, unusual dreams, panic attacks, apathy, aggression, mood elevation, psychiatric disturbances, difficulty thinking, increased libido, sexual disturbances, including difficulty achieving orgasm, delayed ejaculation
• Changes in vision, abnormal eye movements, vision disturbances, including tunnel vision, flashes of light, nystagmus, decreased reflexes, increased activity, dizziness when standing up, skin sensitivity, loss of taste, burning sensation, tremors when moving, disturbances of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, decreased eye movements, tearing, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart activity, heart failure
• Sudden flushing of the face, hot flashes
• Breathing difficulties, dryness of the mucous membranes of the nose, nasal congestion
• Increased salivation, heartburn, numbness around the mouth
• Excessive sweating, rash, chills
• Muscle twitching, joint swelling, muscle stiffness, pain, including muscle pain, neck pain
• Chest pain
• Difficulty or pain when urinating, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood and liver test results (increased creatine phosphokinase activity, alanine aminotransferase, and aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine levels in the blood, decreased potassium levels in the blood)
• Hypersensitivity, facial swelling, hives, angioedema, nasal congestion, nasal bleeding
• Painful menstruation
• Coldness in hands and feet

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

• Changes in taste, feeling of swaying, altered sense of depth, bright vision, loss of vision
• Pupil dilation, strabismus
• Cold sweats, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowing or restriction of body movements
• Difficulty writing
• Parkinsonian syndrome, i.e., symptoms similar to Parkinson's disease, such as tremors, slowed movements (reduced ability to move), and stiffness (muscle stiffness).
• Ascites
• Fluid in the lungs
• Seizures
• Changes in ECG recordings indicating heart rhythm disturbances
• Muscle damage
• Breast discharge, breast enlargement, gynecomastia (breast enlargement in men)
• Amenorrhea
• Kidney failure, decreased urine output, urinary retention
• Decreased white blood cell count
• Abnormal behavior
• Allergic reactions, which can include difficulty breathing, eye inflammation (keratitis), and severe skin reactions, characterized by the occurrence of red, flat, round or oval patches on the torso, often with blisters in their center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and around the eyes. The occurrence of such severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Jaundice (yellowing of the skin and eyes)

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

• Kidney failure
• Kidney inflammation

If you experience swelling of the face or tongue, redness of the skin with blistering or peeling, you should seek medical attention immediately.
Some side effects, such as drowsiness, may occur more frequently because patients with spinal cord injury may be taking other medicines, such as painkillers or muscle relaxants, which have similar side effects to pregabalin. The severity of these side effects may also be greater if these medicines are taken at the same time.
After the marketing authorization of the medicine, the following side effects have been reported: breathing difficulties, shallow breathing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pregamid

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pregamid contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, or 150 mg of pregabalin.
• The other ingredients are: lactose monohydrate, maize starch, talc (E553b), gelatin, titanium dioxide (E171), and black ink (containing shellac, iron oxide black (E172), propylene glycol, potassium hydroxide). The 50 mg and 75 mg capsules also contain iron oxide red (E172). The 50 mg capsules also contain iron oxide yellow (E172).

Pregamid hard capsules are available in PVC/Aluminum blisters containing 14 or 56 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

G.L. Pharma GmbH, Schloßplatz 1, 8502 Lannach, Austria

Manufacturer/Importer:

Delorbis Pharmaceuticals Ltd, 17, Athinon Str., Ergates Industrial Area, 2643 Ergates, Lefkosia, Cyprus

Sofarimex – Indústria Química e Farmacêutica, S.A., Av. das Indústrias - Alto do Colaride, Cacém – Lisboa, 2735-213, Portugal
G.L. Pharma GmbH, Schloßplatz 1, 8502 Lannach, Austria
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland, Tel: 022/ 636 52 23; 636 53 02, [email protected]
Date of last revision of the leaflet: 20.03.2024