Rumbot

Package Leaflet: Information for the User

RUMBOT 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules, 300 mg hard capsules

Pregabalin
Generic Medicine
Please read 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 questions, ask 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 could 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 RUMBOT is and what it is used for
2. What you need to know before taking RUMBOT
3. How to take RUMBOT
4. Possible side effects
5. How to store RUMBOT
6. Contents of the pack and other information

1. What RUMBOT is and what it is used for

RUMBOT belongs to a group of medicines used to treat epilepsy, neuropathic pain, and Generalized Anxiety Disorder (GAD) in adults.
Peripheral and central neuropathic pain: RUMBOT 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, shooting, stabbing, sharp, cramping, discomfort, tingling, numbness, or prickling. Peripheral and central neuropathic pain may also be associated with changes in mood, sleep disturbances, and fatigue (tiredness), and can impact physical and social activities and overall quality of life.
Epilepsy: RUMBOT is used to treat certain types of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe RUMBOT to help manage your epilepsy when your current treatment is not adequately controlling your condition. You will need to take RUMBOT in addition to your existing treatment. RUMBOT is not used as monotherapy but must always be used in combination with other antiepileptic treatments.
Generalized Anxiety Disorder: RUMBOT 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 stress and pressures of everyday life.

2. What you need to know before taking RUMBOT

Do not take RUMBOT

• if you are allergic to the active substance (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 RUMBOT.

• In some patients treated with RUMBOT, 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.
• RUMBOT 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 are familiar with the effects this medicine may have.
• RUMBOT 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 diabetic patients who gain weight during treatment with pregabalin, adjustments to 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 medications 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 RUMBOT; most of these patients were elderly and had cardiovascular disease. If you have a history of cardiovascular disease, you must inform your doctor before starting treatment with this medicine.
• Cases of renal failure have been reported in some patients treated with RUMBOT. If you notice a decrease in urination during treatment with RUMBOT, inform your doctor, as this condition may improve upon discontinuation of the medicine.
• A small number of patients taking antiepileptic medicines such as RUMBOT have experienced suicidal thoughts and self-harming thoughts (hurting oneself). If you experience such thoughts at any time, contact your doctor immediately.
• When RUMBOT 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 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 drug abuse or dependence. Do not take a dose higher than that prescribed.
• Seizures have been reported when taking RUMBOT or shortly after discontinuing it. If seizures occur, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking RUMBOT when they have other medical conditions. Inform your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of breathing difficulties have been reported. If you have neurological disorders, respiratory conditions, impaired kidney function, or are over 65 years of age, your doctor may prescribe a different dosing regimen. Inform your doctor if you experience breathing difficulties or shallow breathing.
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with pregabalin treatment. Stop taking pregabalin and contact your doctor immediately if you develop any symptoms related to these serious skin reactions, as described in section 4.

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

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

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

Driving and using machines
RUMBOT 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.

RUMBOT contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take RUMBOT

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose appropriate for you.
RUMBOT 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 dose appropriate for you and your condition generally ranges between 150 mg and 600 mg per day.
• Your doctor will instruct you to take RUMBOT two or three times a day. If you take the medicine twice daily, take RUMBOT 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 RUMBOT 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 RUMBOT 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 RUMBOT as directed 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 RUMBOT until your doctor tells you to stop treatment.

If you take more RUMBOT than you should
Contact your doctor immediately or go immediately to the nearest hospital. Take the RUMBOT capsule packaging with you. You may feel drowsy, confused, agitated, and restless because you have taken more RUMBOT than you should have.

If you forget to take RUMBOT
It is important to take RUMBOT 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 dose at the scheduled time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking RUMBOT
Do not stop treatment with RUMBOT unless your doctor tells you to. If treatment is to be discontinued, it should be gradually tapered over a period of at least 1 week.
You should know that after stopping treatment with RUMBOT, certain adverse effects may occur in both the short and long term. These include sleep disturbances, headache, nausea, anxiety, diarrhea, flu-like symptoms, seizures, nervousness, depression, pain, sweating, and dizziness.
These symptoms may occur more frequently or be more severe if you have taken RUMBOT 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 out of 10 people:

• Dizziness, drowsiness, headache.

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

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

Uncommon: may occur in up to 1 out of 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 interest in sex, sexual problems including inability to reach orgasm, delayed ejaculation.
• Vision disturbances, 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-related tremor, 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 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 out of 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.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing properly.
• Increased abdominal fluid.
• 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 characterised by flat, non-elevated red 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 occur in up to 1 out of 10,000 people:

• Liver failure.
• Hepatitis (inflammation of the liver).

If you experience swelling of the face or tongue, 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 Pregabalin, 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, consult your doctor or pharmacist.
The following adverse reaction has been reported during the post-marketing phase of the medicine:
breathing difficulties, shallow breathing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website: 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 RUMBOT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle.
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. Pack contents and other information

What RUMBOT contains

• The active substance is pregabalin. Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg or 300 mg of pregabalin.
• The other ingredients are: Capsule contents: lactose monohydrate, pregelatinized corn starch, talc.

Capsule cap for 25 mg, 50 mg, 150 mg and 200 mg capsules
Cap and body of the capsule: Titanium dioxide and gelatin.
Capsule cap for 75 mg and 300 mg capsules
Cap: Titanium dioxide, red iron oxide, yellow iron oxide, gelatin.
Body: Titanium dioxide, gelatin.
Capsule cap for 100 mg capsules
Cap and body of the capsule: Titanium dioxide, red iron oxide, yellow iron oxide, gelatin.
Description of the appearance of RUMBOT and pack contents

RUMBOT capsules are packaged in transparent PVC/PVDC-Al blisters.
RUMBOT 25 mg is available in packs of 14 hard capsules;
RUMBOT 50 mg is available in packs of 21 and 56 hard capsules;
RUMBOT 75 mg is available in packs of 14 and 56 hard capsules;
RUMBOT 100 mg is available in packs of 21 and 56 hard capsules;
RUMBOT 150 mg is available in packs of 14 and 56 hard capsules;
RUMBOT 200 mg is available in packs of 21 and 56 hard capsules;
RUMBOT 300 mg is available in packs of 56 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Elleva Pharma S.r.l. - Via San Francesco 5/7, 80034 Marigliano (NA)
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 – Fisciano (SA)
This leaflet was last updated on
June 2022