Pregamid

Package leaflet: Information for the patient

Pregamid, 25 mg, hard capsules
Pregamid, 50 mg, hard capsules
Pregamid, 75 mg, hard capsules
Pregamid, 150 mg, hard capsules
Pregabalinum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Pregamid is and what it is 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 package and other information

1. What Pregamid is and what it is used for

Pregamid belongs to a group of medicines used in the treatment of epilepsy, neuropathic pain, and generalized anxiety disorders in adults.
Peripheral and central neuropathic pain: Pregamid is used to treat long-term pain caused by nerve damage. Neuropathic pain (of peripheral origin) may be caused by various diseases, such as diabetes or shingles. Pain sensations may be described as burning, tingling, pulsing, stabbing, shooting pain, sharp pain, cramps, aching, pins and needles, or numbness. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue, which may affect the patient's physical and social functioning and overall quality of life.
Epilepsy: Pregamid is used in the treatment of certain types of epilepsy (partial seizures, with or without secondary generalization) in adults. Your doctor may prescribe Pregamid if current treatment does not fully control the disease. Pregamid should always be used as an add-on to ongoing therapy. Pregamid should not be used as monotherapy, but always in combination with other antiepileptic drugs.
Generalised Anxiety Disorder (GAD): Pregamid is used in the treatment of generalised anxiety disorder (GAD). Symptoms of GAD include prolonged, excessive anxiety and worry that are difficult to control. GAD may also cause motor restlessness, irritability or nervous tension, easy fatigability, difficulty concentrating or a feeling of "mind going blank", irritability, increased muscle tension, or sleep disturbances. These symptoms are distinct from the stresses and tensions associated with everyday life.

2. Information before taking Pregamid

When not to take Pregamid
Do not take Pregamid if the patient is allergic to pregabalin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Pregamid, discuss this with your doctor or pharmacist.

• In some patients taking Pregamid, symptoms suggesting allergic reactions have occurred. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If any of these symptoms occur, seek medical advice immediately.
• Treatment with Pregamid has been associated with dizziness and somnolence, which may increase the frequency of accidental injuries (falls) in elderly patients. Therefore, caution should be exercised until the patient knows how this medicine affects them.
• Pregamid may cause blurred vision, loss of vision, or other visual disturbances, most of which are temporary. If any visual disturbances occur, contact your doctor immediately.
• In some patients with diabetes, weight gain associated with pregabalin treatment may necessitate changes in antidiabetic therapy.
• Certain adverse effects such as somnolence may occur more frequently because patients with spinal cord injury may be taking other medications, e.g. analgesics or muscle relaxants, which have similar adverse effects to pregabalin. The severity of adverse effects may also be increased if these medicines are taken concomitantly.
• Cases of heart failure have been reported in some patients taking Pregamid; most often these were elderly patients with cardiovascular disorders. Before using this medicine, inform your doctor about any history of heart disease.
• Cases of renal failure have been reported in some patients taking Pregamid. If the patient notices a decrease in the frequency of urination while taking Pregamid, consult a doctor, as discontinuation of the medicine may lead to resolution of this symptom.
• In a small number of patients taking antiepileptic medicines such as Pregamid, thoughts of self-harm or suicidal thoughts have occurred. If such thoughts occur, contact your doctor immediately.
• When Pregamid is used together with other medicines that may cause constipation (e.g. some analgesics), gastrointestinal disorders (e.g. constipation, intestinal obstruction, or intestinal paralysis) may occur. Contact your doctor if the patient experiences constipation, especially if the patient is predisposed to such disorders.
• Before starting treatment with this medicine, inform your doctor if the patient has previously had alcohol-related illness or has abused or been dependent on drugs. Do not take a dose higher than that recommended by the doctor.
• Seizures have been reported during treatment with Pregamid or shortly after discontinuation of therapy. If the patient experiences seizures, contact your doctor immediately.
• There have been reports of reduced brain function (encephalopathy) in some patients taking Pregamid who also had other underlying diseases. Inform your doctor about all serious illnesses previously suffered, including liver and kidney diseases.
• Cases of breathing difficulties have been reported. If the patient has neurological disorders, respiratory disorders, kidney dysfunction, or is over 65 years of age, the doctor may recommend an alternative dosing regimen. If the patient experiences difficulty breathing or shallow breathing, contact your doctor.
• Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with pregabalin. If the patient develops any of the symptoms of serious skin reactions listed in section 4, discontinue pregabalin and seek immediate medical attention.

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

Pregamid and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregamid and certain other medicines may interact with each other. Pregamid taken concomitantly with other medicines that have a sedative effect (including opioids) may enhance this effect and may lead to respiratory depression, coma, and death. The severity of dizziness, somnolence, and impaired concentration may be greater if Pregamid is taken together with medicines containing:

• oxycodone (used as an analgesic),
• lorazepam (used in the treatment of anxiety disorders),
• alcohol.

Pregamid may be taken with oral contraceptives.

Pregamid, food, and alcohol
Pregamid can be taken with or without food.
During treatment with Pregamid, alcohol consumption is not recommended.

Pregnancy, breastfeeding, and fertility
Pregamid should not be used during pregnancy or breastfeeding unless otherwise decided by a doctor. Women of childbearing potential must use effective contraception.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Pregamid may cause dizziness, somnolence, and concentration disturbances. Do not drive, operate machinery, or perform other potentially hazardous activities until the effect of this medicine on the ability to perform such activities has been determined.

Pregamid contains lactose
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before using this medicine.

3. How to take Pregamid

This medicine should always be taken according to the instructions given by the doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Your doctor will determine the dose of medicine appropriate for you.
Pregamid is intended for oral use only.
Peripheral and central neuropathic pain, epilepsy, or generalized anxiety disorders:

• You should take as many capsules as prescribed by your doctor.
• The usual dose ranges from 150 mg to 600 mg per day.
• Your doctor may recommend taking Pregamid twice or three times a day. If taken twice daily, Pregamid should be taken in the morning and evening, every day at approximately the same time. If taken three times daily, Pregamid should be taken in the morning, afternoon, and evening, every day at approximately the same time.

If you feel that the effect of Pregamid is too strong or too weak, you should consult your doctor or pharmacist.
For elderly patients (over 65 years of age), the usual recommended dose should generally be used, except for patients with kidney disease.
If you have impaired kidney function, your doctor may recommend a different dosing schedule and/or a different dose.
The capsules should be swallowed whole with water.
You should continue taking the medicine for as long as your doctor has instructed.
Taking more Pregamid than prescribed
You should contact your doctor immediately or go to the nearest hospital emergency department. You should bring the Pregamid packaging with you. After taking a dose higher than recommended, you may become drowsy, confused, agitated, or restless. Seizures have also been reported.
Missing a dose of Pregamid
It is important to take Pregamid regularly every day at the same time. If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. In that case, continue your treatment according to the prescribed schedule. Do not take a double dose to make up for a missed dose.
Stopping Pregamid treatment
Do not stop taking Pregamid unless instructed by your doctor. Discontinuation 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, adverse effects may occur. These include sleep disturbances, headache, nausea, anxiety, diarrhoea, 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 been taking Pregamid for a prolonged period.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.

Very common – may affect at least 1 in 10 people:

• Central origin dizziness, drowsiness, headache

Common – may affect less than 1 in 10 people:

• Increased appetite
• Euphoria, confusion, disorientation, decreased libido, irritability
• Difficulty concentrating, clumsiness, memory disturbances, memory loss, tremor, speech difficulties, tingling and numbness, sedation, lethargy, insomnia, fatigue, unusual feeling
• Blurred vision, double vision
• Labyrinthine origin dizziness, balance disorders, falls
• Dryness of the oral mucosa, constipation, vomiting, flatulence, diarrhoea, nausea, bloating sensation
• Erectile dysfunction
• Swelling of the body, including limbs
• Feeling of alcohol intoxication, abnormal gait
• Weight gain
• Muscle spasms, joint pain, back pain, limb pain
• Sore throat

Uncommon – may affect less than 1 in 100 people:

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels
• Changes in self-perception, psychomotor agitation, depression, excitement, mood changes, difficulty finding words, hallucinations, unusual dreams, panic attacks, apathy, aggression, elevated mood, psychiatric disorders, difficulty thinking, increased libido, sexual disorders, including inability to achieve orgasm, delayed ejaculation
• Vision changes, unusual eye movements, visual disturbances including tunnel vision, perception of flashes, jerky movements, reduced reflexes, increased activity, dizziness in standing position, skin sensitivity, loss of taste, burning sensation, tremor during movement, disturbances of consciousness, loss of consciousness, fainting, increased sensitivity to noise, malaise
• Dry eyes, eye swelling, eye pain, impaired eye movement, tearing, eye irritation
• Heart rhythm disturbances, increased heart rate, low blood pressure, high blood pressure, changes in heart function, heart failure
• Sudden facial flushing, hot flushes
• Breathing difficulties, dryness of nasal mucosa, nasal congestion
• Increased salivation, heartburn, perioral tingling
• Excessive sweating, rash, chills, fever
• Muscle tremor, joint swelling, muscle stiffness, pain including muscle pain, neck pain
• Chest pain
• Difficulty or pain during urination, urinary incontinence
• Weakness, thirst, chest tightness
• Changes in blood and liver test results (increased creatine phosphokinase, alanine aminotransferase and aspartate aminotransferase activity, decreased platelet count, neutropenia, increased blood creatinine levels, decreased blood potassium levels)
• Hypersensitivity, facial swelling, itching, urticaria, catarrh, nosebleeds, cough, snoring
• Painful menstruation
• Cold hands and feet

Rare – may affect less than 1 in 1,000 people:

• Taste disturbances, sensation of image oscillation, altered depth perception, vivid vision, vision loss
• Pupil dilation, strabismus
• Cold sweats, throat tightness, tongue swelling
• Pancreatitis
• Difficulty swallowing
• Slowing or limitation of body movements
• Writing difficulties
• Parkinsonism, i.e. symptoms resembling Parkinson's disease, such as tremor, bradykinesia (reduced ability to move) and rigidity (muscle stiffness)
• Ascites
• Presence of fluid in the lungs
• Seizures
• Changes in ECG recording corresponding to heart rhythm disturbances
• Muscle damage
• Breast discharge, breast enlargement, gynaecomastia in men
• Absence of menstruation
• Kidney failure, reduced urine volume, urinary retention
• Decreased white blood cell count
• Inappropriate behaviour
• Allergic reactions, which may include breathing difficulties, eye inflammation (keratitis), and serious skin reactions characterised by appearance of red, flat, disc-shaped or round spots on the trunk, often with blisters in their centre, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and around the eyes. Such 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)

Very rare – may affect less than 1 in 10,000 people:

• Liver failure
• Hepatitis

If the patient develops facial or tongue swelling, skin redness with blistering or skin peeling, immediate medical advice must be sought.

Some adverse effects, such as drowsiness, may occur more frequently in patients with spinal cord injury, as they may be taking other medicines, e.g. analgesics or muscle relaxants, which have similar adverse effects to pregabalin. The severity of these effects may also be greater when such medicines are taken concomitantly.

After the medicine was placed on the market, the following adverse effects have been reported: breathing difficulties, shallow breathing.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the responsible entity. Reporting adverse effects allows more information on the safety of the medicine to be collected.

5. How to store Pregamid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
There are no special requirements for storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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: monohydrate lactose, corn starch, talc (E553b), gelatin, titanium dioxide (E171), and black ink (containing shellac, black iron oxide (E172), propylene glycol, potassium hydroxide). Capsules of 50 mg and 75 mg additionally contain red iron oxide (E172). Capsules of 50 mg additionally contain yellow iron oxide (E172).

Pregamid, hard capsules are available in PVC/Aluminium blisters containing 14 or 56 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For more detailed information, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]