Prelynca

Package Leaflet: Information for the User

Prelynca 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 225 mg hard capsules, 300 mg hard capsules

Pregabalin
Generic medicine
Read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Prelynca is and what it is used for

Prelynca belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Prelynca is used to treat chronic pain caused by damage to the nervous system. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsing, electric shock-like pain, shooting pain, sharp pain, cramping pain, discomfort, tingling, numbness, or stabbing pain. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, and fatigue, and can impact physical and social activities and overall quality of life.
Epilepsy: Prelynca is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Prelynca to help manage your epilepsy when your current treatment is not adequately controlling your seizures. You will need to take Prelynca in addition to your existing treatment. Prelynca is not used as monotherapy, but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder (GAD): Prelynca is used to treat Generalized Anxiety Disorder (GAD). Symptoms of Generalized Anxiety Disorder are characterized by excessive and prolonged anxiety and worry that are difficult to control. Generalized Anxiety Disorder may also cause restlessness or a feeling of being tense or on edge, easy fatigability (tiredness), difficulty concentrating or mental blanks, irritability, muscle tension, or sleep disturbances. These conditions are different from everyday stress and life pressures.

2. What you need to know before taking Prelynca

Do not take Prelynca
If you are allergic to pregabalin or to any of the excipients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Prelynca.

• In some patients treated with Prelynca, symptoms indicating allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue, and throat, as well as widespread skin rash. If any of these reactions occur, contact your doctor immediately.

• Pregabalin has been associated with dizziness and somnolence, which may increase the risk of accidental injury (e.g., falls) in elderly patients. Therefore, exercise caution until you are familiar with the effects this medicine may have on you.

• Prelynca may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If you experience any visual changes, contact your doctor immediately.

• In some diabetic patients who gain weight during treatment with pregabalin, adjustment of diabetes medications may be necessary.

• Some adverse effects, such as somnolence, may be more common in patients with spinal cord injury, as they may be taking other medications to treat, for example, pain or spasticity, which have similar side effects to pregabalin; the severity of these effects may increase when these medicines are taken together.

• Cases of heart failure have been reported in some patients treated with pregabalin; most of these patients were elderly with cardiovascular disease. If you have a history of cardiovascular disease, inform your doctor before starting treatment with this medicine.

• Cases of renal failure have been reported in some patients treated with Prelynca. If during treatment with Prelynca you notice a decrease in urination, inform your doctor, as this condition may improve upon discontinuation of the medicine.

• A small number of patients treated with antiepileptic medicines such as Prelynca have experienced suicidal thoughts and self-harming behaviors (harming oneself). If at any time you have thoughts of this nature, contact your doctor immediately.

• When Prelynca is used together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, intestinal obstruction, or paralytic ileus) may occur. Inform your doctor if you experience constipation, especially if you are prone to this condition.

• Before taking this medicine, inform your doctor if you have a history of alcohol dependence or any substance or medication abuse or dependence. Do not take a higher dose than prescribed.

• Seizures have been reported when taking Prelynca or shortly after discontinuing it. If seizures occur, contact your doctor immediately.

• Cases of reduced brain function (encephalopathy) have occurred in some patients taking Prelynca when other medical conditions are present. Inform your doctor if you have a history of serious medical conditions, including liver or kidney disease.

Children and adolescents
The safety and efficacy of pregabalin 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 Prelynca
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Prelynca and other medicines can affect each other (interaction). When Prelynca is taken together with other medicines, it may enhance adverse effects observed with these medicines, including respiratory depression and coma. The intensity of dizziness, somnolence, and reduced concentration may increase if Prelynca is taken together with medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for treatment of anxiety)
Alcohol
Prelynca may be taken concurrently with oral contraceptives.

Prelynca with food and drink and alcohol
Prelynca capsules may be taken with or without food.
It is advisable not to drink alcohol during treatment with Prelynca.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Prelynca should not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise. Women of childbearing potential must use an effective method of contraception.

Driving and using machines
Prelynca may cause dizziness, somnolence, and reduced concentration. You should not drive, operate complex machinery, or engage in potentially hazardous activities until you have determined whether this medicine affects your ability to perform such tasks.

3. How to take Prelynca

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.
Prelynca is for oral use only.

Epilepsy or Generalized Anxiety Disorder:

• Take the number of capsules prescribed by your doctor.
• The appropriate dose for you and your condition generally ranges between 150 mg and 600 mg per day.
• Your doctor will instruct you to take Prelynca two or three times a day. If you take the medicine twice daily, take Prelynca once in the morning and once in the evening, always approximately at the same time. If you take the medicine three times a day, take Prelynca once in the morning, once in the afternoon, and once in the evening, always approximately at the same time.

If you feel that the effect of Prelynca is too strong or too weak, talk to your doctor or pharmacist.
If you are elderly (over 65 years of age), you should normally take Prelynca unless you have kidney problems.
Your doctor may prescribe you a different dosing schedule and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Prelynca until your doctor tells you to stop treatment.

If you take more Prelynca than you should
Contact your doctor immediately or go immediately to the nearest hospital. Bring the pack of Prelynca capsules with you. You may feel drowsy, confused, agitated, and restless because you have taken more Prelynca than you should have.

If you forget to take Prelynca
It is important to take Prelynca capsules regularly every day at the same time. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Prelynca
Do not stop taking Prelynca unless your doctor tells you to. If treatment is to be stopped, it should be discontinued gradually over a period of at least 1 week.
You should be aware that after stopping treatment with Prelynca, undesirable effects may occur in the short and long term. These include sleep disturbances, headache, nausea, anxiety, diarrhoea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness. These symptoms may occur more frequently or be more severe if you have taken Prelynca for a longer period of time.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common: may occur in more than 1 person out of 10:

• Dizziness.
• Drowsiness.
• Headache.

Common: may occur in up to 1 person out of 10:

• Increased appetite.
• Feeling of excitement, confusion, disorientation, decreased sexual interest, irritability.
• Attention disturbances, clumsiness, memory impairment, memory loss, tremor, difficulty speaking, tingling sensation, numbness, sedation, lethargy, insomnia, fatigue, feeling strange.
• Blurred vision, double vision.
• Vertigo, balance disorders, falls.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea, nausea, abdominal swelling.
• Erectile dysfunction.
• Body swelling, including hands and feet.
• Feeling of drunkenness, abnormal gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, limb pain.
• Sore throat.

Uncommon: may occur in up to 1 person out of 100:

• Loss of appetite, weight loss, low blood sugar levels, high blood sugar levels.
• Altered self-perception, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, altered dreams, panic attacks, apathy, aggression, euphoric mood, mental impairment, difficulty in thinking, increased sexual interest, sexual problems including inability to reach orgasm, delayed ejaculation.
• Visual disturbances, abnormal eye movements, visual abnormalities including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noise, feeling unwell.
• Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation.
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Vasomotor disturbances (flushing), hot flushes.
• Breathing difficulties, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensation around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, joint swelling, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or painful urination, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood test results and liver function tests (increased blood creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, reduced platelet count, neutropenia, increased creatinine levels, decreased potassium levels).
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

Rare: may occur in up to 1 person out of 1,000:

• Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, visual brightness, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, throat tightness, tongue swelling.
• Pancreatic inflammation.
• Swallowing difficulties.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Fluid accumulation in the abdomen.
• Fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) abnormalities corresponding to heart rhythm disorders.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast enlargement in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behaviour.
• Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterized by rash, blistering, skin peeling, and pain).

If you experience swelling of the face or tongue, or if your skin becomes red and blisters start to form, or if skin peeling occurs, you must contact your doctor immediately.

Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be taking other medicines to treat, for example, pain or spasticity, which have similar side effects to Pregabalin, and the severity of these effects may increase when these medicines are taken together.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prelynca

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prelynca contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.

The excipients are:
Capsule contents: Pregelatinized starch, Mannitol, Maize starch, Talc
Capsule shell: Gelatin, Titanium dioxide (E171), Red iron oxide (E172) (75 mg,
100 mg, 300 mg), Red iron oxide (E172) and yellow iron oxide (E172) (200 mg, 225 mg)
Printing ink: Shellac, Black iron oxide (E172), Propylene glycol (E1520), Ammonium hydroxide
(E527)

Description of the appearance of Prelynca and contents of the pack
25 mg capsules: White hard capsules, marked with the inscription "25" on the body of the capsule.
50 mg capsules: White hard capsules, marked with the inscription "50" on the body of the capsule.
75 mg capsules: White and light orange hard capsules, marked with the inscription "75" on the body of the capsule.
100 mg capsules: Light orange hard capsules, marked with the inscription "100" on the body of the capsule.
150 mg capsules: White hard capsules, marked with the inscription "150" on the body of the capsule.
200 mg capsules: Red hard capsules, marked with the inscription "200" on the body of the capsule.
225 mg capsules: Red and white hard capsules, marked with the inscription "225" on the body of the capsule.
300 mg capsules: White and orange hard capsules, marked with the inscription "300" on the body of the capsule.

Prelynca is available in cardboard packs containing the appropriate number of PVC/aluminum blisters of:
14 or 56 hard capsules of 25 mg
7, 14 or 56 hard capsules of 50 mg
14 or 56 hard capsules of 75 mg
7, 14 or 56 hard capsules of 100 mg
14 or 56 hard capsules of 150 mg
14 or 56 hard capsules of 200 mg
14 or 56 hard capsules of 225 mg
14 or 56 hard capsules of 300 mg

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)

Manufacturer
Pharmathen International SA,
Industrial Park, Building Block 5,
Sapes, 69300 Greece
Tel: + 30 25 320 31376
E-Mail: [email protected]
or
Pharmathen S.A.,
6, Dervenakion str.
153 51 Pallini,
Attiki,
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:

This leaflet was last updated on