Pregenaq

Patient Information Leaflet: Information for the User

Pregenaq 20 mg/ml Oral Solution

Pregabalin
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Pregenaq Oral Solution is and what it is used for

Pregenaq Oral Solution belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: Pregenaq Oral Solution is used to treat chronic pain caused by nerve damage. Various diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. Pain sensations may be described as heat, burning, pulsation, throbbing pain, stabbing pain, sharp pain, cramping pain, discomfort, tingling, numbness, or prickling 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: Pregenaq Oral Solution is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization – seizures that start in one specific part of the brain). Your doctor will prescribe Pregenaq Oral Solution to help manage your epilepsy when your current treatment does not adequately control your condition.
You must take Pregenaq Oral Solution in addition to the treatment you are already receiving. Pregenaq Oral Solution is not used as monotherapy, but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: Pregenaq Oral Solution is used for the treatment of 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, difficulty concentrating or mental blanks, 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 Pregenaq Oral Solution

Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Discontinue use of pregabalin and contact your doctor immediately if you experience any symptoms related to these serious skin reactions, as described in section 4.

Do not take Pregenaq Oral Solution
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 Pregenaq Oral Solution.

• Allergic-type reactions have been reported in some patients treated with Pregenaq Oral Solution. These reactions 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.
• Pregenaq Oral Solution has been associated with dizziness and somnolence, which may increase the risk of accidental injuries (falls) in elderly patients. Therefore, exercise caution until you become familiar with the effects of this medicine.
• Pregabalin may cause blurred vision or loss of vision, or other visual disturbances, many of which are transient. If you experience any visual disturbance, 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.
• Cases of heart failure have been reported in some patients treated with Pregenaq Oral Solution; most of these patients were elderly and had cardiovascular disease. If you have a history of heart disease, inform your doctor before starting treatment with this medicine.
• Cases of renal impairment have been reported in some patients treated with Pregenaq Oral Solution. If you notice a decrease in urine output during treatment with Pregenaq Oral Solution, inform your doctor, as this condition may improve upon discontinuation of the medicine.
• A small number of patients taking antiepileptic medicines such as Pregenaq Oral Solution have experienced suicidal thoughts and self-harming thoughts (harming oneself). If you have thoughts of this nature at any time, contact your doctor immediately.
• When Pregenaq Oral Solution 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 paralysis) 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 drug abuse or dependence. Do not take a dose higher than prescribed.
• Seizures have been reported when taking Pregenaq Oral Solution or shortly after discontinuation. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking Pregenaq Oral Solution when other medical conditions are present. 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 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 Pregenaq Oral Solution
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregenaq Oral Solution and certain other medicines may interact with each other. When Pregenaq Oral Solution is taken together with certain medicines, it may enhance the adverse effects associated with these medicines, including respiratory depression and coma.
Dizziness, somnolence, and reduced concentration may be intensified if Pregenaq Oral Solution is taken together with other medicines containing:
Oxycodone – (used as an analgesic)
Lorazepam – (used for the treatment of anxiety)
Alcohol
Pregenaq Oral Solution can be taken together with oral contraceptives.

Pregenaq Oral Solution with food, drinks, and alcohol
Pregenaq Oral Solution can be taken with or without food.
It is recommended not to consume alcohol during treatment with Pregenaq Oral Solution.

Pregnancy, breastfeeding, and fertility
Pregenaq Oral Solution should not be taken during pregnancy or while breastfeeding, unless otherwise directed by your doctor. Women of childbearing potential must use an effective method of contraception. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Pregenaq Oral Solution may cause dizziness, somnolence, and reduced concentration. You should not drive vehicles, operate complex machinery, or engage in potentially hazardous activities until you are certain that this medicine does not impair your ability to perform such tasks.

Pregenaq Oral Solution contains 36.9 mg of sodium (a main component of table salt) per 30 ml. This corresponds to 1.9% of the maximum daily recommended dietary intake for an adult.

Pregenaq Oral Solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).

3. How to take Pregenaq Oral Solution

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.
Peripheral and central neuropathic pain, epilepsy, or Generalized Anxiety Disorder:

• Take the oral solution according to your doctor's instructions.
• The dose, which has been tailored for your condition, generally ranges between 150 mg (7.5 ml) and 600 mg (30 ml) per day.
• Your doctor will instruct you to take Pregenaq Oral Solution either twice or three times a day. If you take Pregenaq Oral Solution twice daily, take it once in the morning and once in the evening, approximately at the same time each day. If you take it three times a day, take it once in the morning, once in the afternoon, and once in the evening, approximately at the same time each day.

If you feel that the effect of Pregenaq Oral Solution is too strong or too weak,
consult your doctor or pharmacist.
If you are elderly (over 65 years of age), you should usually take Pregenaq Oral Solution as directed unless you have kidney problems.
Your doctor may prescribe a different dosing schedule and/or a different dose if you have kidney problems.
Continue taking Pregenaq Oral Solution until your doctor tells you to stop.
Administration:
Instructions for use

Pregenaq Oral Solution must be administered orally only.

1. Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).
2. At first opening only: an oral syringe is supplied together with a press-in bottle adapter (Press-In Bottle Adapter, PIBA). This is the device inserted into the neck of the bottle to facilitate withdrawal of the solution using the oral syringe. Place the bottle on a flat surface, insert the adapter into the neck of the bottle while keeping the surface flat, and press down firmly on the adapter (Figure 2).
3. Push the plunger of the syringe down to the base of the syringe (towards its tip) to remove excess air. Attach the syringe to the adapter with a slight twisting motion (Figure 3).
4. Invert the bottle (with the syringe inserted) and draw the liquid into the syringe by pulling the plunger downward, just beyond the marking corresponding to the volume in millilitres (ml) prescribed by the doctor (Figure 4). Remove air bubbles from the syringe by pushing the plunger down to the appropriate measurement mark.
5. Place the bottle upright again, with the syringe still attached to the adapter/bottle (Figure 5).
6. Remove the syringe from the bottle/adapter (Figure 6).
7. Empty the contents of the syringe directly into the mouth by pushing the plunger of the syringe towards the base of the syringe (Figure 7).

Caution: steps 4–7 may need to be repeated up to three times to obtain the total dose (Table 1).
[For example, for a 150 mg dose (7.5 ml), two withdrawals from the bottle will be required to obtain the full dose. Using the oral syringe, first withdraw 5 ml and empty the contents of the syringe directly into the mouth; then withdraw another 2.5 ml using the oral syringe and empty the remaining contents into the mouth.]

8. Rinse the syringe by drawing water into the syringe and pushing the plunger to the base of the syringe, repeating this process at least three times (Figure 8).
9. Replace the cap on the bottle (leaving the adapter in place in the neck of the bottle) (Figure 9).

Table 1. Withdrawals using the oral syringe to administer the prescribed dose of Pregenaq Oral Solution

If you take more Pregenaq Oral Solution than you should
Contact your doctor immediately or go immediately to the nearest hospital. Take the
package or the bottle of Pregenaq Oral Solution with you. You may feel drowsy, confused, agitated or
restless if you have taken more Pregenaq Oral Solution than you should. Seizures have also been reported.

If you forget to take Pregenaq Oral Solution
It is important to take Pregenaq Oral Solution 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 as scheduled. Do not take a double dose to make up for the missed dose.

If you stop taking Pregenaq Oral Solution
Do not stop treatment with Pregenaq Oral Solution unless your doctor has told you to do so. If treatment is to be stopped, discontinuation should be carried out gradually over a period of at least 1 week.

You should be aware that after stopping long-term or short-term treatment with Pregenaq Oral Solution, 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 Pregenaq Oral Solution 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 everyone gets them.
Very common: may affect more than 1 in 10 people
Dizziness, drowsiness, headache.
Common: may affect up to 1 in 10 people

• Increased appetite.
• Feeling of excitement, confusion, disorientation, decreased sexual interest, irritability.
• Attention disorders, 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 bloating.
• Difficulty in erection.
• Body swelling, including extremities.
• Feeling of drunkenness, gait abnormalities.
• Weight gain.
• Muscle cramps, 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 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 ideation, increased sexual interest, sexual problems including inability to achieve orgasm, delayed ejaculation.
• Visual disturbances, eye movement abnormalities, visual alterations 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 of malaise.
• Dry eyes, eye swelling, eye pain, eye weakness, eye tearing, eye irritation.
• Heart rhythm disorders, increased heart rate, low blood pressure, high blood pressure, heart rate alterations, heart failure.
• 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 blood creatinine, decreased blood potassium).
• Hypersensitivity, facial swelling, itching, urticaria, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

Rare: may affect 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.
• Difficulty swallowing.
• 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 flat, non-elevated reddish patches on the trunk, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These 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).
• Parkinsonism, Parkinson-like symptoms such as tremor, bradykinesia (reduced ability to move), and rigidity (muscle stiffness).

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

• Liver failure.
• Hepatitis (liver inflammation).

If you experience facial or tongue swelling, or if your skin turns 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 Pregenaq Oral Solution, and the severity of these effects may increase when these medicines are taken together.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pregenaq Oral Solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening, do not store above 25°C and use within 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pregenaq Oral Solution contains
The active substance is: pregabalin. Each ml contains 20 mg of pregabalin.
The other components are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate (E339), sucralose (E955), strawberry flavour,
sodium hydroxide (for pH adjustment), purified water.
Description of the appearance of Pregenaq Oral Solution and contents of the pack
Pregenaq 20 mg/ml Oral Solution is a colourless solution with a characteristic strawberry aroma in a white HDPE bottle containing 250 ml of oral solution, in a cardboard box. The box contains one HDPE bottle or two HDPE bottles with a nominal capacity of 250 ml, each fitted with tamper-proof screw caps made of HDPE and child-resistant closures. The box also contains a CE-marked 5 ml oral dosing syringe with intermediate graduations of 0.25 ml and one or two press-in bottle adapters (PIBA).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy
Manufacturer:
Anfarm Hellas S.A.
61 km NAT. RD. ATHENS-LAMIA,
Schimatari Viotias, 32009, Greece
This Patient Information Leaflet has been last revised on