Pregabalin HCS

Package leaflet: Information for the user

Pregabalin HCS 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 this entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pregabalin HCS 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 HCS 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, stabbing pain, sharp pain, cramps, discomfort, tingling, numbness, or pricking pain. Peripheral and central neuropathic pain may also be associated with mood changes, sleep disturbances, fatigue (tiredness), and may impact physical and social activities and overall quality of life.
Epilepsy: Pregabalin HCS is used to treat certain forms of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe Pregabalin HCS to help manage your epilepsy when your current treatment does not adequately control your condition. You will need to take Pregabalin HCS in addition to your existing treatment. Pregabalin HCS is not used as monotherapy, but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: Pregabalin HCS 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 memory lapses, irritability, muscle tension, or sleep disturbances. These conditions are different from the everyday stress and pressures of daily life.

2. What you need to know before taking Pregabalin HCS

Do not take Pregabalin HCS
if you are allergic to pregabalin or to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Pregabalin HCS.

• In some patients treated with pregabalin, 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, you must contact your doctor immediately.
• Pregabalin 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 the effects this medicine may have on you.
• Pregabalin HCS may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If any visual disturbance occurs, you must contact your doctor immediately.
• In some diabetic patients who gain weight during treatment with Pregabalin HCS, 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 HCS, 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; most of these patients were elderly with cardiovascular disease.
• 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. If during treatment with Pregabalin HCS you notice a decrease in urination, inform your doctor, as this condition may improve by discontinuing the use of this medicine.
• A small number of patients treated with antiepileptic medicines such as Pregabalin HCS have experienced suicidal thoughts and self-harming behaviors (harming oneself). If at any time you experience thoughts of this nature, contact your doctor immediately.
• When Pregabalin HCS is used together with other medicines that may cause constipation (such as certain pain medications), gastrointestinal problems (e.g., constipation, intestinal obstruction, or intestinal paralysis) may occur. Inform your doctor if you develop constipation, especially if you are prone to this condition.
• Before taking this medicine, inform your doctor if you have a history of alcohol or medicine dependence. Do not take more medicine than prescribed.
• Seizures have been reported in some patients during pregabalin treatment or shortly after discontinuation. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred during treatment with pregabalin in some patients who had other medical conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.

Children and adolescents
Studies have not been conducted to demonstrate the safety and efficacy of pregabalin in children and adolescents (under 18 years of age), and therefore Pregabalin HCS should not be used in this age group.
Other medicines and Pregabalin HCS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Pregabalin HCS and other medicines can interact with each other. When Pregabalin HCS is taken together with other medicines, it may enhance the adverse effects associated with these medicines, including respiratory failure and coma. The intensity of dizziness, somnolence, and reduced concentration may increase if Pregabalin HCS is taken together with medicines containing:

• Oxycodone (used as an analgesic)
• Lorazepam (used for the treatment of anxiety)
• Alcohol Pregabalin HCS can be taken in combination with oral contraceptives.

Pregabalin HCS with food, drinks, and alcohol
Pregabalin HCS capsules can be taken with or without food.
It is advisable not to drink alcohol during treatment with Pregabalin HCS.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregabalin HCS should not be taken during pregnancy or while breastfeeding, unless your doctor has advised otherwise. Women of childbearing potential should use an effective method of contraception.
Driving and use of machines
Pregabalin HCS 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 impairs your ability to perform such tasks.

3. How to take Pregabalin HCS

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you.
Pregabalin HCS is for oral use only.
Peripheral and central neuropathic pain, epilepsy, or Generalized Anxiety Disorder:

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

If you feel that the effect of Pregabalin HCS is too strong or too weak, discuss this with your
doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should normally take Pregabalin HCS unless you
have kidney problems. Your doctor may prescribe you a different dosage and/or dose adjustment if you have kidney problems.
Swallow the capsule whole with water.
Continue taking Pregabalin HCS until your doctor tells you to stop treatment.
If you take more Pregabalin HCS than you should
Contact your doctor or go immediately to the nearest hospital. Bring the Pregabalin HCS packaging with you. You may feel drowsy, confused, agitated, and restless because you have taken more Pregabalin HCS than you should have. Seizures have also been reported.
If you forget to take Pregabalin HCS
It is important to take Pregabalin HCS 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, skip the missed dose and take the next one as scheduled. Do not take a double dose to make up for forgotten doses.
If you stop taking Pregabalin HCS
Do not stop treatment with Pregabalin HCS unless your doctor tells you to. If treatment is to be stopped, it should be discontinued gradually over at least 1 week.
You should know that after stopping long-term or short-term treatment with Pregabalin HCS, 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 severely if you have taken Pregabalin HCS for a longer period of time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience swelling of the face or tongue, or if your skin becomes red and blisters start to
form, or skin peeling occurs, contact your doctor immediately.

Very common side effects (may affect more than 1 in 10 people):

• Dizziness, drowsiness, headache.

Common side effects (may affect less than 1 in 10 people):

• Increased appetite.
• Feeling of excitement, confusion, disorientation, loss of libido, 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 distension.
• Erectile dysfunction.
• Swelling of the body including hands and feet.
• Feeling of drunkenness, abnormalities in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, lower back pain.
• Sore throat.

Uncommon side effects (may affect less than 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, mood changes, mental fatigue, difficulty thinking, increased sexual drive, sexual problems including inability to reach orgasm, delayed ejaculation.
• Vision changes, eye movement abnormalities, visual disturbances including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness upon standing, skin sensitivity, loss of taste, burning sensation, movement tremor, loss of consciousness, fainting, increased sensitivity to noise, malaise.
• Dry eyes, eye swelling, eye pain, ocular discomfort, eye irritation, watery eyes.
• Heart rhythm disturbances, 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.
• Chest pain.
• Difficulty or painful urination, incontinence.
• Weakness, thirst, feeling of tightness in the chest.
• Changes in blood test results and liver function tests (elevated serum creatine phosphokinase, elevated alanine aminotransferase, elevated aspartate aminotransferase, reduced platelet count, neutropenia, elevated creatinine, reduced potassium levels).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstruation.
• Feeling cold in hands and feet.

Rare side effects (may affect less than 1 in 1,000 people):

• Altered sense of smell, sensation of oscillation in the visual field, altered depth perception, flashes of light, vision loss.
• Dilated pupils, strabismus.
• Cold sweats, sensation of tightness in the throat, tongue swelling.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Fluid accumulation in the abdomen.
• Fluid in the lungs.
• Seizures.
• Electrocardiogram (ECG) changes indicating heart rhythm disturbances.
• Muscle damage.
• Breast discharge, abnormal breast growth, breast development in men.
• Interruption of 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 characterised by rash, blisters, skin peeling and pain).
• Jaundice (yellowing of the skin and eyes).

Very rare side effects (may affect 1 in 10,000 people):

• Liver failure.
• Hepatitis (inflammation of the liver). 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 side effects similar to those of Pregabalin HCS, 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, 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 HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp./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 HCS 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 other ingredients contained inside the capsule are:
pregelatinized maize starch, talc (E553b).

• The other components of the 25 mg hard capsules are: titanium dioxide (E171), gelatin (E441), black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.

• The other components of the 50 mg and 75 mg hard capsules are: titanium dioxide (E171), gelatin (E441), yellow iron oxide (E172), black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.

• The other components of the 100 mg hard capsules are: titanium dioxide (E171), gelatin (E441), red iron oxide (E172), white printing ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in the capsule shell.

• The other components of the 150 mg hard capsules are: titanium dioxide (E171), gelatin (E441), red iron oxide (E172), yellow iron oxide (E172), black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520)) in the capsule shell.

• The other components of the 200 mg and 225 mg hard capsules are: titanium dioxide (E171), gelatin (E441), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172),
  black printing ink (shellac (E904), black iron oxide (E172), propylene glycol (E1520))
  in the capsule shell.

• The other components of the 300 mg hard capsules are: titanium dioxide (E171), gelatin (E441), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), white printing ink (shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171)) in the capsule shell.

Description of the appearance of Pregabalin HCS and package contents
Hard capsules.
25 mg hard capsules: the capsule body is white, the cap is white. The cap is marked with the black code P25. The capsule contents are white to off-white powder. Capsule length: 13.8–14.8 mm.
50 mg hard capsules: the capsule body is white, the cap is light yellow. The cap is marked with the black code P50. The capsule contents are white to off-white powder. Capsule length: 15.3–16.2 mm.
75 mg hard capsules: the capsule body is yellowish-brown, the cap is yellowish-brown. The cap is marked with the black code P75. The capsule contents are white to off-white powder. Capsule length: 13.8–14.8 mm.
100 mg hard capsules: the capsule body is reddish-brown, the cap is reddish-brown. The cap is marked with the white code P100. The capsule contents are white to off-white powder. Capsule length: 15.3–16.2 mm.
150 mg hard capsules: the capsule body is white, the cap is yellowish-brown. The cap is marked with the black code P150. The capsule contents are white to off-white powder. Capsule length: 17.2–18.3 mm.
200 mg hard capsules: the capsule body is brown, the cap is brown. The cap is marked with the black code P200. The capsule contents are white to off-white powder. Capsule length: 18.7–19.8 mm.
225 mg hard capsules: the capsule body is white, the cap is brown. The cap is marked with the black code P225. The capsule contents are white to off-white powder. Capsule length: 18.7–19.8 mm.
300 mg hard capsules: the capsule body is white, the cap is dark brown. The cap is marked with the black code P300. The capsule contents are white to off-white powder. Capsule length: 20.0–22.1 mm.
Pregabalin HCS is available in packs of 14, 56 or 84 hard capsules, divided into blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorized in the European Economic Area countries under the
following names: