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REWISCA 225 MG HARD CAPSULES

Active substance(s): PREGABALIN

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Package leaflet: Information for the user

Rewisca® 25 mg hard capsules
Rewisca® 50 mg hard capsules
Rewisca® 75 mg hard capsules
Rewisca® 100 mg hard capsules
Rewisca® 150 mg hard capsules
Rewisca® 200 mg hard capsules
Rewisca® 225 mg hard capsules
Rewisca® 300 mg hard capsules
pregabalin
Read all of this leaflet carefully before you start taking
this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

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

1. What Rewisca is and what it is used for
Rewisca belongs to a group of medicines used to treat
epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Epilepsy: Rewisca is used to treat a certain form of
epilepsy (partial seizures with or without secondary
generalisation) in adults. Your doctor will prescribe
Rewisca for you to help treat your epilepsy when your
current treatment is not controlling your condition. You
should take Rewisca in addition to your current treatment.
Rewisca is not intended to be used alone, but should
always be used in combination with other anti-epileptic
treatment.
Generalised Anxiety Disorder: Rewisca is used to treat
Generalised Anxiety Disorder (GAD). The symptoms of
GAD are prolonged excessive anxiety and worry that are
difficult to control. GAD can also cause restlessness or
feeling keyed up or on edge, being easily fatigued (tired),
having difficulty concentrating or mind going blank, feeling
irritable, having muscle tension or sleep disturbance. This
is different to the stresses and strains of everyday life.

2. What you need to know before you take
Rewisca
Do not take Rewisca:
• if you are allergic to pregabalin or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor or pharmacist before taking Rewisca.
• Some patients taking pregabalin have reported
symptoms suggesting an allergic reaction.These
symptoms include swelling of the face, lips, tongue, and
throat, as well as diffuse skin rash. Should you
experience any of these reactions, you should contact
your physician immediately.
• pregabalin has been associated with dizziness and
somnolence, which could increase the occurrence of
accidental injury (fall) in elderly patients. Therefore, you
should be careful until you are used to any effect the
medicine might have.
• pregabalin may cause blurring or loss of vision, or other
changes in eyesight, many of which are temporary. You
should immediately tell your doctor if you experience any
changes in your vision.
• Some patients with diabetes who gain weight while
taking pregabalin may need an alteration in their diabetic
medicines.
• There have been reports of heart failure in some patients
when taking pregabalin; these patients were mostly
elderly with cardiovascular conditions.

Before taking this medicine you should tell your doctor
if you have a history of heart disease.
• There have been reports of kidney failure in some
patients when taking pregabalin. If while taking Rewisca
you notice decreased urination, you should tell your
doctor as stopping the medicine may improve this.
• A small number of people being treated with antiepileptics such as Rewisca have had thoughts of harming
or killing themselves. If at any time you have these
thoughts, immediately contact your doctor.
• When Rewisca is taken with other medicines that may
cause constipation (such as some types of pain
medicines) it is possible that gastrointestinal problems
may occur (e.g., constipation, blocked or paralysed
bowel). Tell your doctor if you experience constipation,
especially if you are prone to this problem.
• Before taking this medicine you should tell your doctor if
you have a history of alcoholism or any drug abuse or
dependence. Do not take more medicine than prescribed.
• There have been reports of convulsions when taking
pregabalin or shortly after stopping pregabalin. If you
experience a convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function
(encephalopathy) in some patients taking pregabalin
when they have other conditions. Tell your doctor if you
have a history of any serious medical conditions, including
liver or kidney disease.
Children and adolescents
The safety and efficacy in children and adolescents (under

18 years of age) has not been established and therefore,
Rewisca should not be used in this age group.
Other medicines and Rewisca
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Rewisca and certain other medicines may influence each
other (interaction). When taken with certain other
medicines, Rewisca may potentiate the side effects seen
with these medicines, including respiratory failure and
coma. The degree of dizziness, sleepiness and decreased
concentration may be increased if Rewisca is taken
together with medicinal products containing:
• Oxycodone (used as a pain-killer)
• Lorazepam (used for treating anxiety)
• Alcohol
Rewisca may be taken with oral contraceptives.
Rewisca with food, drink and alcohol
Rewisca capsules may be taken with or without food.
It is advised not to drink alcohol while taking Rewisca.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Rewisca should not be taken during pregnancy or when
breast-feeding, unless you are told otherwise by your
doctor.
Effective contraception must be used by women of
child-bearing potential.

Driving and using machines
Rewisca may cause dizziness, sleepiness and
decreased concentration. You should not drive, operate
complex machinery or engage in other potentially
hazardous activities until you know whether this medicine
affects your ability to perform these activities.

If you are an elderly patient (over 65 years of age), you
should take Rewisca normally except if you have problems
with your kidneys. Your doctor may prescribe a different
dosing schedule and/or dose if you have problems with
your kidneys.
Swallow the capsule whole with water.
Continue taking Rewisca until your doctor tells you to stop.

3. How to take Rewisca

If you take more Rewisca than you should
Call your doctor or go to the nearest hospital emergency
unit immediately. Take your box of Rewisca capsules with
you. You may feel sleepy, confused, agitated, or restless as
a result of taking more Rewisca than you should.

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Your doctor will determine what dose is appropriate for you.
Rewisca is for oral use only.
Epilepsy or Generalised Anxiety Disorder:
• Take the number of capsules as instructed by your
doctor.
• The dose, which has been adjusted for you and your
condition, will generally be between 150 mg and
600 mg each day.
• Your doctor will tell you to take Rewisca either twice or
three times a day. For twice a day take Rewisca once in
the morning and once in the evening, at about the same
time each day. For three times a day take Rewisca once
in the morning, once in the afternoon and once in the
evening, at about the same time each day.
If you have the impression that the effect of Rewisca is too
strong or too weak, talk to your doctor or pharmacist.

If you forget to take Rewisca
It is important to take your Rewisca capsules regularly at the
same time each day. If you forget to take a dose, take it as
soon as you remember unless it is time for your next dose. In
that case, just carry on with the next dose as normal. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Rewisca
Do not stop taking Rewisca unless your doctor tells you to.
If your treatment is stopped it should be done gradually
over a minimum of 1 week.
After stopping long and short-term Rewisca treatment, you
need to know that you may experience certain side effects.
These include, trouble sleeping, headache, nausea, feeling
anxious, diarrhoea, flu-like symptoms, convulsions,
nervousness, depression, pain, sweating, and dizziness.

These symptoms may occur more commonly or severely if
you have been taking Rewisca for a longer period of time.
If you have any further questions on 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.
If you experience swollen face or tongue or if your skin
turns red and starts to blister or peel you should seek
immediate medical advice.
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 elation, confusion, disorientation, decrease in
sexual interest, irritability.
• Disturbance in attention, clumsiness, memory
impairment, loss of memory, tremor, difficulty with
speaking, tingling feeling, numbness, sedation, lethargy,
insomnia, fatigue, feeling abnormal.
• Blurred vision, double vision.
• Vertigo, problems with balance, fall.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea,
nausea, swollen abdomen.
• Difficulties with erection.
• Swelling of the body including extremities.






Feeling drunk, abnormal style of walking.
Weight gain.
Muscle cramp, joint pain, back pain, pain in limb.
Sore throat.

Uncommon (may affect up to 1 in 100 people):
• Loss of appetite, weight loss, low blood sugar, high
blood sugar.
• Change in perception of self, restlessness, depression,
agitation, mood swings, difficulty finding words,
hallucinations, abnormal dreams, panic attacks, apathy,
aggression, elevated mood, mental impairment, difficulty
with thinking, increase in sexual interest, problems with
sexual functioning including inability to achieve a sexual
climax, delayed ejaculation.
• Changes in eyesight, unusual eye movement, changes
in vision including tunnel vision, flashes of light, jerky
movements, reduced reflexes, increased activity,
dizziness on standing, sensitive skin, loss of taste,
burning sensation, tremor on movement, decreased
consciousness, loss of consciousness, fainting,
increased sensitivity to noise, feeling unwell.
• Dry eyes, eye swelling, eye pain, weak eyes, watery
eyes, eye irritation.
• Heart rhythm disturbances, increased heart rate, low
blood pressure, high blood pressure, changes in
heartbeat, heart failure.
• Flushing, hot flushes.
• Difficulty breathing, dry nose, nasal congestion.

• Increased saliva production, heartburn, numb around
mouth.
• Sweating, rash, chills, fever.
• Muscle twitching, joint swelling, muscle stiffness, pain
including muscle pain, neck pain.
• Breast pain.
• Difficulty with or painful urination, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (blood creatinine
phosphokinase increased, alanine amino transferase
increased, aspartate aminotransferase increased,
platelet count decreased, neutropaenia, increase in
blood creatinine, decrease in blood potassium).
• Hypersensitivity, swollen face, itchiness, hives, runny
nose, nose bleed, cough, snoring.
• Painful menstrual periods.
• Coldness of hands and feet.
Rare (may affect up to 1 in 1,000 people):
• Abnormal sense of smell, swinging vision, altered
perception of depth, visual brightness, vision loss.
• Dilated pupils, cross eyes.
• Cold sweat, tightness of the throat, swollen tongue.
• Inflammation of the pancreas.
• Difficulty in swallowing.
• Slow or reduced movement of the body.
• Difficulty with writing properly.
• Increased fluid in the abdomen.
• Fluid in the lungs

• Convulsions
• Changes in the recording of electrical changes (ECG) in
the heart which correspond to heart rhythm disturbances
• Muscle damage.
• Breast discharge, abnormal breast growth, breast
growth in males.
• Interrupted menstrual periods.
• Kidney failure, reduced urine volume, urinary retention.
• Decrease in white blood cell count.
• Inappropriate behaviour.
• Allergic reactions (which may include difficulty breathing,
inflammation of the eyes (keratitis) and a serious skin
reaction characterized by rash, blisters, peeling skin and
pain).
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
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Rewisca
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. The expiry date refers
to the last day of that month.

Do not store above 30°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other
information
What Rewisca 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 pregabalin.
• The other ingredients are pregelatinised starch, talc
(E553b) in capsule contents.
• The other ingredients of 25 mg hard capsules are
titanium dioxide (E171), gelatin (E441), black printing ink
(shellac (E904), black iron oxide (E172), N-butyl alcohol,
purified water, propylene glycol (E1520), dehydrated
ethanol, isopropyl alcohol, ammonium hydroxide (E527))
in capsule shell.
• The other ingredients of 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), N-butyl alcohol, purified water,
propylene glycol (E1520), dehydrated ethanol, isopropyl
alcohol, ammonium hydroxide (E527)) in capsule shell.
• The other ingredients of 100 mg hard capsules are
titanium dioxide (E171), gelatin (E441), red iron oxide

(E172), white printing ink (shellac (E904), dehydrated
alcohol, isopropyl alcohol, butyl alcohol, propylene glycol
(E1520), ammonium hydroxide (E527), purified water,
potassium hydroxide (E525), titanium dioxide (E171)) in
capsule shell.
• The other ingredients of 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), N-butyl alcohol,
purified water, propylene glycol (E1520), dehydrated
ethanol, isopropyl alcohol, ammonium hydroxide (E527))
in capsule shell.
• The other ingredients of 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), N-butyl alcohol, purified water,
propylene glycol (E1520), dehydrated ethanol, isopropyl
alcohol, ammonium hydroxide (E527)) in capsule shell.
• The other ingredients of 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), dehydrated
alcohol, isopropyl alcohol, butyl alcohol, propylene glycol
(E1520), ammonium hydroxide (E527), purified water,
potassium hydroxide (E525), titanium dioxide (E171)) in
capsule shell.

What Rewisca looks like and contents of the pack
25 mg hard capsules: The body of the capsule is white
colour, the cap of the capsule is white colour. Capsule cap
is imprinted with black mark P25. The content of the
capsule is white to off white powder.
50 mg hard capsules: The body of the capsule is white
colour, the cap of the capsule is pale yellow colour.
Capsule cap is imprinted with black mark P50. The content
of the capsule is white to off white powder.
75 mg hard capsules: The body of the capsule is brownish
yellow colour, the cap of the capsule is brownish yellow
colour. Capsule cap is imprinted with black mark P75. The
content of the capsule is white to off white powder.
100 mg hard capsules: The body of the capsule is reddish
brown colour, the cap of the capsule is reddish brown
colour. Capsule cap is imprinted with white mark P100. The
content of the capsule is white to off white powder.
150 mg hard capsules: The body of the capsule is white
colour, the cap of the capsule is yellowish brown colour.
Capsule cap is imprinted with black mark P150. The
content of the capsule is white to off white powder.
200 mg hard capsules: The body of the capsule is brown
colour, the cap of the capsule is brown colour. Capsule cap
is imprinted with black mark P200. The content of the
capsule is white to off white powder.
225 mg hard capsules: The body of the capsule is white
colour, the cap of the capsule is brown colour. Capsule cap

is imprinted with black mark P225. The content of the
capsule is white to off white powder.
300 mg hard capsules: The body of the capsule is white
colour, the cap of the capsule is dark brown colour.
Capsule cap is imprinted with white mark P300. The
content of the capsule is white to off white powder.
Rewisca is available in boxes of 14, 21, 56, 70, 84, 100 or
112 (2x56) hard capsules in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Consilient Health Ltd., 5th floor, Beaux Lane House,
Mercer Street Lower, Dublin 2, Ireland
Manufacturer
KRKA, d. d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto, Slovenia
This leaflet was last revised in 04/2015.

P0343

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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