Patient Information Leaflet

Pregabalin TecniGen 25 mg hard capsules

Pregabalin TecniGen 50 mg hard capsules
Pregabalin TecniGen 75 mg hard capsules
Pregabalin TecniGen 100 mg hard capsules
Pregabalin TecniGen 150 mg hard capsules
Generic medicine

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What this leaflet contains

What Pregabalin TecniGen is and what it is used for
What you need to know before taking Pregabalin TecniGen
How to take Pregabalin TecniGen
Possible side effects
How to store Pregabalin TecniGen
Contents of the pack and other information

1. What Pregabalin TecniGen is and what it is used for

Pregabalin TecniGen belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregabalin TecniGen 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, throbbing 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 (tiredness), and can impact physical and social functioning and overall quality of life.
Epilepsy: Pregabalin TecniGen is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor has prescribed Pregabalin TecniGen to help manage your epilepsy when your current treatment is not adequately controlling your condition. You will need to take Pregabalin TecniGen in addition to your existing therapy.
Pregabalin TecniGen is not used as monotherapy, but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: Pregabalin TecniGen 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 fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension, or sleep disturbances. These conditions are different from the everyday stress and pressures of normal life.

2. What you need to know before taking Pregabalin TecniGen

Do not take Pregabalin TecniGen
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 or pharmacist before taking Pregabalin TecniGen.

In some patients treated with Pregabalin TecniGen, 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 TecniGen has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, you should exercise caution until you become familiar with how this medicine affects you.
Pregabalin TecniGen may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If any visual disturbance occurs, 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 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.
There have been reports of heart failure in some patients treated with Pregabalin TecniGen; these patients were mostly elderly with cardiovascular diseases. If you have a history of cardiovascular disease, you must inform your doctor before starting treatment with this medicine.
There have been reports of renal failure in some patients treated with Pregabalin TecniGen. If during treatment with Pregabalin TecniGen you notice a decrease in urination, inform your doctor, as this condition may improve upon discontinuation of this medicine.
A small number of patients treated with antiepileptic medicines such as Pregabalin TecniGen have experienced suicidal thoughts and self-harming behaviors (self-injury). If you experience any such thoughts at any time, contact your doctor immediately.
When Pregabalin TecniGen is used together with other medicines that may cause constipation (such as certain types of pain medications), gastrointestinal problems (e.g., constipation, bowel 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 history of substance or medication abuse or dependence. Do not take a dose higher than that prescribed.
Seizures have been reported when taking Pregabalin TecniGen or shortly after discontinuation. If seizures occur, contact your doctor immediately.
Cases of reduced brain function (encephalopathy) have occurred in some patients taking Pregabalin TecniGen when they have other underlying conditions. Inform your doctor if you have a history of other 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, and therefore pregabalin should not be used in this age group.
Other medicines and Pregabalin TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregabalin TecniGen and other medicines may interact with each other. When Pregabalin TecniGen is taken together with other medicines, it may enhance adverse effects associated with these medicines, including respiratory failure and coma. The intensity of dizziness, somnolence, and reduced concentration may increase if Pregabalin TecniGen is taken together with medicines containing:
Oxycodone – (used as an analgesic) Lorazepam
(used to treat anxiety) Alcohol
Pregabalin TecniGen can be taken together with oral contraceptives.
Pregabalin TecniGen with food, drinks, and alcohol
Pregabalin TecniGen capsules may be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin TecniGen.
Pregnancy and breastfeeding
Pregabalin TecniGen should not be taken during pregnancy or breastfeeding unless otherwise directed by your doctor. Women of childbearing potential should use an effective method of contraception. If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Pregabalin TecniGen may cause dizziness, somnolence, and reduced concentration. You should not drive, operate complex machinery, or engage in potentially hazardous activities until you know whether this medicine affects your ability to perform such tasks.
Pregabalin TecniGen contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Pregabalin TecniGen

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

Peripheral and central neuropathic pain, 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 Pregabalin TecniGen two or three times a day. If you take the medicine twice daily, take Pregabalin TecniGen once in the morning and once in the evening, approximately at the same time each day. If you take the medicine three times a day, take Pregabalin TecniGen 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 Pregabalin TecniGen is too strong or too weak, discuss this with your doctor or pharmacist.
If you are elderly (over 65 years of age), you should normally take Pregabalin TecniGen as directed, unless you have kidney problems.
Your doctor may prescribe you a different dosing schedule and/or dose if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Pregabalin TecniGen until your doctor tells you to stop.

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

If you forget to take Pregabalin TecniGen
It is important to take Pregabalin TecniGen 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 that case, skip the missed dose and take the next one as scheduled. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pregabalin TecniGen
Do not stop treatment with Pregabalin TecniGen unless your doctor tells you to. If treatment is to be discontinued, it should be done gradually over a period of at least 1 week.
You should be aware that after stopping Pregabalin TecniGen treatment, both in the short and long term, certain adverse effects may occur. 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 Pregabalin TecniGen for a longer period of time.

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

4. Possible side effects

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

Very common: may occur in more than 1 in 10 people:

Dizziness, drowsiness, headache.

Common: may occur in up to 1 in 10 people:

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 and abdominal swelling.
Erectile dysfunction.
Swelling of the body, 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 in 100 people:

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 achieve 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 sensitivity 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 serum creatine phosphokinase, increased alanine aminotransferase, increased aspartate aminotransferase, decreased platelet count, neutropenia, increased creatinine, decreased potassium levels)
Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring
Painful menstrual cycles
Cold hands and feet

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

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
Decreased white blood cell count
Inappropriate behaviour
Allergic reactions (which may include breathing difficulties, eye inflammation (keratitis), and a severe skin reaction characterized by rash, blisters, skin peeling and pain)
Jaundice (yellowing of the skin and eyes)

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

Liver failure
Hepatitis (liver inflammation)

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 frequent 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 effects, including those not listed in this leaflet, talk to 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 Pregabalin TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and packaging after "Exp.". The expiry date refers to the last day of that 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 Pregabalin TecniGen contains
Pregabalin TecniGen 25 mg
The active substance is pregabalin. Each hard capsule contains 25 mg of pregabalin.
The excipients are: monohydrate lactose, maize starch, talc. The 25 mg capsules contain gelatin and titanium dioxide (E171).
Pregabalin TecniGen 50 mg
The active substance is pregabalin. Each hard capsule contains 50 mg of pregabalin.
The excipients are: monohydrate lactose, maize starch, talc. The 50 mg capsules contain gelatin and titanium dioxide (E171).
Pregabalin TecniGen 75 mg
The active substance is pregabalin. Each hard capsule contains 75 mg of pregabalin.
The excipients are: monohydrate lactose, maize starch, talc. The 75 mg capsules contain gelatin and titanium dioxide (E171) (body and cap), erythrosine, FD&C Red No. 3, yellow iron oxide (E172), red iron oxide (E172) (cap).
Pregabalin TecniGen 100 mg
The active substance is pregabalin. Each hard capsule contains 100 mg of pregabalin.
The excipients are: monohydrate lactose, maize starch, talc. The 100 mg capsules contain gelatin, titanium dioxide (E171), erythrosine, FD&C Red No. 3, yellow iron oxide (E172), red iron oxide (E172) (body and cap).
Pregabalin TecniGen 150 mg
The active substance is pregabalin. Each hard capsule contains 150 mg of pregabalin.
The excipients are: monohydrate lactose, maize starch, talc. The 150 mg capsules contain gelatin and titanium dioxide (E171).

Description of the appearance of Pregabalin TecniGen and the contents of the pack
Pregabalin TecniGen 25 mg capsules are hard capsules with a white body and a white cap.
Pregabalin TecniGen 50 mg capsules are hard capsules with a white body and a white cap.
Pregabalin TecniGen 75 mg capsules are hard capsules with a white body and a red cap.
Pregabalin TecniGen 100 mg capsules are hard capsules with a red body and a red cap.
Pregabalin TecniGen 150 mg capsules are hard capsules with a white body and a white cap.

Pregabalin TecniGen 25 mg is available in blisters containing 14 hard capsules.
Pregabalin TecniGen 50 mg is available in blisters containing 21 hard capsules.
Pregabalin TecniGen 75 mg is available in blisters containing 14 and 56 hard capsules.
Pregabalin TecniGen 100 mg is available in blisters containing 21 hard capsules.
Pregabalin TecniGen 150 mg is available in blisters containing 14 and 56 hard capsules.

Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Manufacturers
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra
Portugal
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora
Portugal