RUMBOT 25 mg Hard Capsule

Зміст інструкції

1. RUMBOT 25 mg hard capsules, 50 mg hard capsules, 75 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules
   1. What is RUMBOT and what is it 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

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

RUMBOT 200 mg hard capsules
RUMBOT 300 mg hard capsules
Pregabalin
Equivalent Medicinal Product
Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is RUMBOT and what is it used for

RUMBOT belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.

Peripheral and central neuropathic pain:RUMBOT is used to treat chronic pain caused by damage to the nervous system. Several diseases can cause peripheral neuropathic pain, such as diabetes or herpes zoster. Pain sensations can be described as heat, burning, throbbing, pulsating, stabbing, sharp, cramping, suffering, tingling, numbness, pricking. Peripheral and central neuropathic pain can also be associated with mood changes, sleep disturbances and fatigue (tiredness) and can have an impact on physical and social activity and overall quality of life.

Epilepsy:RUMBOT is used to treat certain forms of epilepsy in adults (partial seizures with or without secondary generalization). Your doctor will prescribe RUMBOT to help you treat epilepsy when the treatment you are already receiving does not control the condition. You will need to take RUMBOT in addition to the treatment you are already undergoing. RUMBOT is not used alone, but must always be associated with other antiepileptic treatments.

Generalised Anxiety Disorder:RUMBOT is used to treat Generalised Anxiety Disorder (GAD). The symptoms of Generalised Anxiety Disorder are characterised by excessive and prolonged anxiety and worry that are difficult to control. Generalised Anxiety Disorder can also cause restlessness or a feeling of tension or being on edge, easy fatigue (tiredness), difficulty concentrating or memory lapses, irritability, muscle tension or sleep disturbances. These conditions are different from stress and the tensions of everyday life.

2. What you need to know before taking RUMBOT

Do not take RUMBOT

• if you are allergic to the active ingredient (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 indicative of allergic reactions have been reported. These symptoms include swelling of the face, lips, tongue and throat, as well as a widespread skin rash. If you experience any of these reactions, contact your doctor immediately.
• RUMBOT has been associated with dizziness and drowsiness which may increase the risk of accidental injuries (falls) in the elderly. Therefore, you should be careful until you are familiar with the effects that the medicine may have.
• RUMBOT can cause blurred 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 patients with diabetes who gain weight during treatment with pregabalin, it may be necessary to adjust the medicines for diabetes.
• Some undesirable effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have undesirable effects similar to those of 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 RUMBOT; these patients were mostly elderly with cardiovascular disease. If you have a history of cardiovascular disease before starting treatment with thismedicine you must inform your doctor.
• There have been reports of kidney failure in some patients treated with RUMBOT. If you notice a reduction in urination during treatment with RUMBOT, you should inform your doctor because stopping the use of this medicine this condition may improve.
• A small number of patients treated with antiepileptic medicines like RUMBOT have experienced suicidal thoughts and self-harm (hurting yourself). At any time if you have thoughts of this kind, contact your doctor immediately.
• When RUMBOT is used together with other medicines that can cause constipation (such as some types of pain medications) gastrointestinal problems (e.g. constipation, blocked or paralyzed bowel) may occur. Tell your doctor if you experience constipation, especially if you are prone to this problem.
• Before taking this medicine tell your doctor if you have a history of alcohol dependence or any abuse or dependence on medicines. Do not take a dose of medicine higher than the one prescribed.
• Cases of seizures have been reported when taking RUMBOT or immediately after stopping it. If you experience seizures, contact your doctor immediately.
• Cases of reduced brain function (encephalopathy) have occurred in some patients taking RUMBOT when they have other conditions. Tell your doctor if you have a history of other serious medical conditions, including liver or kidney disease.
• Cases of difficulty breathing have occurred. If you suffer from nervous system diseases, respiratory diseases, kidney impairment or if you are over 65 years of age, your doctor may prescribe a different dosing regimen. Tell your doctor if you have difficulty breathing or shallow breathing.
• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with pregabalin. Stop using pregabalin and contact your doctor immediately if you develop any of the symptoms related to these severe skin reactions, 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
RUMBOT and other medicines can influence each other (interaction). When RUMBOT
is taken together with other medicines it can enhance the undesirable effects that are observed with
these medicines, including respiratory failure and coma.
The intensity of dizziness, drowsiness and reduced concentration may increase
if RUMBOT is taken together with other medicines containing:
Oxycodone – (used as a pain reliever)
Lorazepam – (used for the treatment of anxiety)
Alcohol
RUMBOT can be taken at the same time as oral contraceptives.

RUMBOT with food, drinks and alcohol
The capsules of RUMBOT can 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 told you otherwise. Women of childbearing potential should use
an effective method of contraception. If you are pregnant, suspect or are planning a
pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.

Driving and operating machinery
RUMBOT can cause dizziness, drowsiness and reduced concentration. You should not drive,
operate complex machinery or undertake potentially dangerous activities until you
have ascertained whether this medicine alters your ability to perform these activities.

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

3. How to take RUMBOT

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The doctor will establish the appropriate dose 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 appropriate dose for you and your condition generally varies between 150 mg and 600 mg per day.
• Your doctor will tell you to take RUMBOT two or three times a day. If you take the medicine twice a day, take RUMBOT once in the morning and once in the evening, always at approximately the same time. 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 at approximately 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 take RUMBOT normally unless you have
kidney problems.
The doctor may prescribe you a different dosage and/or a different dose if you have kidney problems.
Swallow the capsule whole with water.
Continue to take RUMBOT until your doctor tells you to stop the treatment.

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

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 if you have not taken it unless
it is time to take the next dose. In this case, take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

If you stop taking RUMBOT
Do not stop treatment with RUMBOT unless your doctor has told you to. If the
treatment is stopped, it must be done gradually over at least 1
week.
You should know that after stopping treatment with RUMBOT in the short and long term
some undesirable effects may occur. These include sleep disturbances, headache,
nausea, anxiety, diarrhea, flu-like symptoms, convulsions, nervousness, depression, pain,
sweating and dizziness.
These symptoms may occur more frequently or severely if you have taken RUMBOT for
a longer period of time.
If you have any doubts 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 everybody 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.
• Difficulty with concentration, clumsiness, impaired memory, 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, diarrhea, nausea and abdominal bloating.
• Difficulty with erection.
• Swelling of the body, including hands and feet.
• Feeling of intoxication, abnormalities in gait.
• Weight gain.
• Muscle cramps, joint pain, back pain, pain in the limbs.
• 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 with ideation, increased sexual interest, sexual problems including inability to reach orgasm, delayed ejaculation.
• Changes in vision, abnormalities in eye movement, visual disturbances including tunnel vision, flashes of light, jerky movements, reduced reflexes, increased activity, dizziness when standing up, skin sensitivity, loss of taste, burning sensation, tremor during movement, reduced consciousness, loss of consciousness, fainting, increased sensitivity to noises, feeling unwell.
• Dry eyes, swollen eyes, eye pain, eye weakness, watery eyes, eye irritation.
• Irregular heartbeat, increased heart rate, low blood pressure, high blood pressure, changes in heartbeat, heart failure.
• Vasomotor disorders (flushing), hot flashes.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, heartburn, loss of sensation around the mouth.
• Sweating, rash, chills, fever.
• Muscle contractions, swollen joints, muscle stiffness, pain including muscle pain, neck pain.
• Breast pain.
• Difficulty or pain when urinating, incontinence.
• Weakness, thirst, feeling of tightness in the chest.
• 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, reduced potassium.
• Hypersensitivity, facial swelling, itching, hives, runny nose, nosebleeds, cough, snoring.
• Painful menstrual cycles.
• Cold hands and feet.

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

• Alteration of smell, sensation of visual field oscillation, altered depth perception, visual brilliance, loss of vision.
• Dilated pupils, strabismus.
• Cold sweats, feeling of constriction in the throat, swelling of the tongue.
• Inflammation of the pancreas.
• Difficulty swallowing.
• Slowed or reduced body movement.
• Difficulty writing appropriately.
• Increased fluid in the abdomen.
• Presence of fluid in the lungs.
• Convulsions.
• Changes in the electrocardiogram (ECG) corresponding to heart rhythm disturbances.
• Muscle damage.
• Breast secretions, abnormal breast growth, breast growth in men.
• Interrupted menstrual cycles.
• Kidney failure, reduced urine volume, urinary retention.
• Reduced white blood cell count.
• Inappropriate behavior.
• Allergic reactions that can include difficulty breathing, eye inflammation (keratitis) and a severe skin reaction characterized by reddish, non-raised patches on the trunk, shaped like targets or circles, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe 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, symptoms similar to Parkinson's disease; such as tremor, bradykinesia (decreased ability to move), and rigidity (muscle stiffness). Very rare: may affect up to 1 in 10,000 people:
• Liver failure.
• Hepatitis (inflammation of the liver).

If you experience facial or tongue swelling or if the skin becomes red and blisters begin to form or skin peeling occurs, you should contact your doctor immediately.
Some side effects, such as drowsiness, may be more common because patients with spinal cord injury may be treated with other medicines to treat, for example, pain or spasticity, which have side effects similar to those of Pregabalin and the severity of these effects may increase when these medicines are taken together.
If any side effect occurs, including those not listed in this leaflet, tell your doctor or pharmacist.
The following adverse reaction has been reported in the post-marketing phase of the medicine:
difficulty breathing, shallow breathing.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 RUMBOT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack or the 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 any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RUMBOT contains

• The active ingredient 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 of 25 mg, 50 mg, 150 mg and 200 mg capsules
Cap and Body of the capsule: Titanium dioxide and gelatin.

Capsule cap of 75 mg and 300 mg capsules
Cap: Titanium dioxide, red iron oxide, yellow iron oxide, gelatin.
Body: Titanium dioxide, gelatin.

Capsule cap of 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 contents of the pack
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 Authorisation 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 in
June 2022