Solifenacin Clonmel 5 mg Film-coated Tablets

Main information

  • Trade name:
  • Solifenacin Clonmel 5 mg Film-coated Tablets
  • Dosage:
  • 5 milligram(s)
  • Pharmaceutical form:
  • Film-coated tablet
  • Prescription type:
  • Product subject to prescription which may be renewed (B)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Solifenacin Clonmel 5 mg Film-coated Tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Drugs for urinary frequency and incontinence; solifenacin

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA0126/288/001
  • Authorization date:
  • 28-07-2017
  • Last update:
  • 13-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Solifenacin Clonmel 5mg

Film-coated Tablets

Solifenacin Clonmel 10mg

Film-coated Tablets

Solifenacin succinate

Package leaflet: Information for the user

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 Solifenacin Clonmel is and what it is used

2. What

need

know

before

take

Solifenacin Clonmel

3. How to take Solifenacin Clonmel

4. Possible side effects

5. How to store Solifenacin Clonmel

6. Contents of the pack and other information

1. What Solifenacin Clonmel is and

what it is used for

active

substance

Solifenacin

Clonmel

belongs

group

called

anticholinergics.

These medicines are used to reduce the activity

of an overactive bladder. This enables you to wait

longer before having to go to the bathroom and

increases the amount of urine that can be held by

your bladder.

Solifenacin Clonmel is used to treat the symptoms

of a condition called overactive bladder. These

symptoms include: having a strong, sudden urge

to urinate without prior warning, having to urinate

frequently or wetting yourself because you could

not get to the bathroom in time.

2. What you need to know before you

take Solifenacin Clonmel

DO NOT take Solifenacin Clonmel

if you are unable to pass water or to empty your

bladder completely (urinary retention)

if you have a severe stomach or bowel condi-

tion (including toxic megacolon, a complication

associated with ulcerative colitis)

if you suffer from the muscle disease called

myasthenia gravis, which can cause an extreme

weakness of certain muscles

if you suffer from increased pressure in the

eyes, with gradual loss of eye sight (glaucoma)

if you are allergic to solifenacin or any of the

other

ingredients

this

medicine

(listed

section 6)

if you are undergoing kidney dialysis

if you have severe liver disease

if you suffer

from severe kidney disease

moderate liver disease AND at the same time

being

treated

with

medicines

that

decrease the removal of Solifenacin Clonmel

from the body (for example, ketoconazole).

Your doctor or pharmacist will have informed

you if this is the case

Inform your doctor if you have or have ever had

above

mentioned

conditions

before

treatment with this medicine starts

Warnings and precautions

Talk to your doctor or pharmacist before taking

Solifenacin Clonmel

if

have

trouble

emptying

your

bladder

(bladder

obstruction)

have

difficulty

passing urine (e.g. a thin urine flow). Risk of

accumulation of urine in the bladder (urinary

retention) is much higher

if you have some obstruction of the digestive

system (constipation)

if

risk

your

digestive

system

slowing down (stomach and bowel movements).

Your doctor will have informed you if this is the

case

if you suffer from severe kidney disease

if you have moderate liver disease

if you have a stomach tear (hiatus hernia) or

heartburn

if you have a disorder of the nervous system

called autonomic neuropathy

Inform your doctor if you have or have ever had

above

mentioned

conditions

before

treatment with this medicine starts.

Before starting Solifenacin Clonmel, your doctor

will assess whether there are other causes for

your need to pass urine frequently, for example

heart failure (insufficient pumping power of the

heart) or kidney disease. If you have a urinary

tract infection, your doctor will prescribe you an

antibiotic (a treatment against particular bacterial

infections).

Children and adolescents

Solifenacin Clonmel is not to be used in children or

adolescents under 18 years.

Other medicines and Solifenacin Clonmel

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other medi-

cines.

It is especially important to inform your doctor if

you are taking:

other anticholinergic medicines, as the effects

and side effects of both medications could be

increased. Please ask your doctor if your medi-

cine belongs to this group

cholinergics, as they can reduce the effect of

Solifenacin Clonmel. Please ask your doctor if

your medicine belongs to this group

medicines, like metoclopramide and cisapride,

which make the digestive system work faster.

Solifenacin Clonmel can reduce their effect

medicines,

like

ketoconazole,

itraconazole

(medicines

used

treat

fungal

infections),

ritonavir, nelfinavir (medicines used to treat HIV

infections) and verapamil, diltiazem (medicines

used to treat high blood pressure and heart

diseases). These medicines decrease the rate

at which Solifenacin Clonmel is broken down by

the body

medicines

like

rifampicin

(medicine

used

treat tuberculosis and other bacterial infections)

and phenytoin, carbamazepine (medicines used

to treat epilepsy). They may increase the rate

at which Solifenacin Clonmel is broken down by

the body

medicines such as bisphosphonates, that can

cause or exacerbate inflammation of the gullet

(oesophagitis). Please ask your doctor if your

medicine belongs to this group

Solifenacin Clonmel with food and drink

This medicine can be taken with or without food,

depending on your preference.

Pregnancy and breast-feeding

You should not use Solifenacin Clonmel if you are

pregnant unless your doctor thinks it is necessary.

Do not use this medicine if you are breast-feeding

as solifenacin may pass into your breast milk.

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.

Driving and using machines

Solifenacin Clonmel may cause blurred vision and

sometimes sleepiness or tiredness. If you suffer

from any of these side effects, do not drive or

operate machinery.

Solifenacin Clonmel contains lactose

If you have been told by your doctor that you

have an intolerance to some sugars, contact your

doctor before taking this medicinal product.

3. How to take Solifenacin Clonmel

Instructions for proper use

Always take this medicine exactly as your doctor

has told you. Check with your doctor or pharma-

cist if you are not sure.

Dosage

The recommended dose is 5 mg per day, unless

your doctor has told you to take 10 mg per day.

Method of administration

You should swallow the tablet whole with some

liquid, e.g. a glass of water. It can be taken with or

without food, according to your preference. Do not

crush the tablets.

Use in children and adolescents

Solifenacin Clonmel is not to be used in children or

adolescents under 18 years.

If you take more Solifenacin Clonmel than you

should

If you have taken too much Solifenacin Clonmel

or if a child has accidentally taken this medicine,

contact your doctor or pharmacist immediately.

Produkt/Product:

Packmittel/Packaging:

STADA Mat.-Nr./Mat.-No.:

Hersteller/Manufacturer:

STADA Art.-Nr./Art.-No.:

Format/Size:

Schriftgröße/Font-size:

PZN/EAN:

Laetus-Code:

Flattermarke/Collating mark:

1. Farbe/Colour:

2. Farbe/Colour:

3. Farbe/Colour:

4. Farbe/Colour:

5. Farbe/Colour:

6. Farbe/Colour:

7. Farbe/Colour:

8. Farbe/Colour:

Version:

Datum/Date:

Agentur/Agency:

Grafik erstellt von/Graphic made by:

Genehmigt/Approved

Hersteller Art.-Nr./Manuf. Art.-No.:

Solifenacin 5 mg,

Solifenacin 10 mg FTA CHC IE

GI / PIL

9281602 1802

149052, 149053

HEMOFARM AD

1347119

148 x 420 mm

9, 10, 14 pt

7340

BLACK 100%

4. Umlauf 23.03.2018

TYPE SERVICE

Solifenacin_FTA_CHC_IE_GI_148x420_9281602_1802.indd 1

23.03.18 16:43

Symptoms of overdose may include: headache,

mouth,

dizziness,

drowsiness

blurred

vision, perceiving things that are not there (hallu-

cinations), over-excitability, seizures (convulsions),

difficulty breathing, elevated heart rate (tachy-

cardia),

accumulation

urine

bladder

(urinary retention) and dilated pupils (mydriasis).

If you forget to take Solifenacin Clonmel

If you forget to take a dose at the usual time, take

it as soon as you remember, unless it is time to

take your next dose. Never take more than one

dose per day. Do not take a double dose to make

up for a forgotten dose. If you are in doubt, always

consult your doctor or pharmacist.

If you stop taking Solifenacin Clonmel

If you stop taking this medicine, your symptoms of

overactive bladder may return or worsen. Always

consult your doctor, if you are considering stop-

ping the treatment.

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.

Stop

taking

Solifenacin

Clonmel

seek

medical help immediately if you notice any of

the following side effects

allergic attack, or a severe skin reaction (e.g.

blistering and peeling of the skin)

angioedema

(skin

allergy

that

results

swelling that occurs in the tissue just below

the surface of the skin) with airway obstruction

(difficulty in breathing) has been reported in

some patients on solifenacin succinate.

Solifenacin Clonmel may cause the following other

side effects:

Very common (may affect more than 1 in 10

people)

dry mouth

Common (may affect up to 1 in 10 people)

blurred vision

constipation,

nausea,

indigestion

with

symp-

toms

such

abdominal

fullness,

abdom-

inal

pain,

burping,

nausea,

heartburn

(dyspepsia), stomach discomfort

Uncommon (may affect up to 1 in 100 people)

urinary tract infection, bladder infection

sleepiness

impaired sense of taste (dysgeusia)

dry (irritated) eyes

dry nasal passages

acid reflux (gastrooesophageal reflux)

dry throat

dry skin

difficulty in passing urine

tiredness

accumulation of fluid in the lower legs (oedema)

Rare (may affect up to 1 in 1,000 people)

lodging of a large amount of hardened stool in

the large intestine (faecal impaction)

build-up of urine in the bladder due to inability

to empty the bladder (urinary retention)

dizziness, headache

vomiting

itching, rash

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

hallucinations, confusion

allergic rash

known

(frequency

cannot

estimated

from the available data)

decreased appetite, high levels of blood potas-

sium which can cause abnormal heart rhythm

increased pressure in the eyes

changes in the electrical activity of the heart

(ECG), irregular heartbeat, feeling your heart-

beat, faster heart beat

voice disorder

liver disorder

muscle weakness

renal disorder

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace,

IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide

more information on the safety of this medicine.

5. How to store Solifenacin Clonmel

This

medicinal

product

does

require

special temperature storage conditions. Store in

original package in order to protect from humidity.

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 carton and blister after

EXP. The expiry date refers to the last day of that

month.

Do not use this medicine if the pack is damaged

or shows signs of tampering.

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

pack

other

information

What Solifenacin Clonmel contains

The active substance is solifenacin succinate.

Each film-coated tablet contains 5 mg solifenacin

succinate equivalent to 3.8 mg solifenacin.

Each film-coated tablet contains 10 mg solifenacin

succinate equivalent to 7.5 mg solifenacin.

The other ingredients are

Tablet core

Lactose

monohydrate,

Maize

starch,

Hypromel-

lose, Magnesium stearate.

Film-coating

Hypromellose, Titanium Dioxide (E171), Macrogol

8000, Talc and Iron Oxide Yellow (E172) (5 mg

tablet), Iron Oxide Red (E172) (10 mg tablet).

What

Solifenacin

Clonmel

looks

like

contents of the pack

Solifenacin Clonmel 5 mg film-coated tablets are

round, light yellow, biconvex film-coated tablets.

Solifenacin Clonmel 10 mg film-coated tablets are

round, light pink, biconvex film-coated tablets.

Solifenacin

Clonmel

film-coated

tablets are supplied in blister packs of 10, 20, 30,

40, 50, 60, 80, 90, 100, 105, 120, 150, 180 and

200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufac-

turer

Marketing Authorisation Holder

Clonmel Healthcare Ltd,

Waterford Road, Clonmel, Co. Tipperary,

Ireland

Manufacturer

STADA Arzneimittel AG,

Stadastrasse 2-18, D-61118 Bad Vilbel,

Germany

Centrafarm Services B.V.,

Nieuwe Donk 9, 4879 AC Etten-Leur,

Netherlands

STADA Arzneimittel GmbH,

Muthgasse 36/2, 1190 Wien,

Austria

STADA Nordic ApS,

Marielundvej 46A, 2730 Herlev,

Denmark

Clonmel Healthcare Ltd,

Waterford Road, Clonmel, Co. Tipperary,

Ireland

This medicinal product is authorised in the

Member States of the EEA under the following

names:

Solifenacinesuccinaat CF 5 mg, 10 mg,

filmomhulde tabletten

Solifenacin STADA 5 mg, 10 mg

Filmtabletten

Solifenacine EG 5 mg, 10 mg filmomhulde

tabletten

Solifenacinsuccinat AL 5 mg, 10 mg

Filmtabletten

Solifenacin STADA 5 mg, 10 mg

filmovertrukne tabletter

Solifenacina STADA 5 mg, 10 mg

comprimidos recubiertos con película EFG

Solifenacin STADA 5 mg, 10 mg

kalvopäällysteinen tabletti

SOLIFENACINE EG 5 mg, 10 mg,

comprimé pelliculé

Solifenacin Clonmel 5 mg, 10 mg

film-coated tablets

Solifenacine EG 5 mg, 10 mg

comprimé pelliculé

Solifenacin STADA

Solifenacin STADA 5 mg, 10 mg

filmdragerad tablett

Solifenacin STADA 5 mg, 10 mg

This leaflet was revised in May 2017.

CLONMEL HEALTHCARE LTD

CLONMEL, IRELAND

9281602 1802 IE

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23.03.18 16:43