Solifenacin Clonmel 10 mg Film-coated Tablets

Main information

  • Trade name:
  • Solifenacin Clonmel 10 mg Film-coated Tablets
  • Dosage:
  • 10 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 10 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:
  • PA0126/288/002
  • Authorization date:
  • 28-07-2017
  • Last update:
  • 13-12-2018

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

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Package leaflet: Information for the user

Solifenacin Clonmel 5mg Film-coated Tablets

Solifenacin Clonmel 10mg Film-coated Tablets

Solifenacin succinate

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 for

2. What you need to know before you 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

The active substance of Solifenacin Clonmel belongs to the 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 condition (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 of this medicine (listed in section 6)

if you are undergoing kidney dialysis

if you have severe liver disease

if you suffer from severe kidney disease or moderate liver disease AND at the same time are being

treated with medicines that may 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 any of the above mentioned conditions before treatment

with this medicine starts

Warnings and precautions

Talk to your doctor or pharmacist before taking Solifenacin Clonmel

if you have trouble emptying your bladder (bladder obstruction) or have difficulty in 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)

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if you are at risk of 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 any of the 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 medicines.

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 medicine 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 to 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 to 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

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Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 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.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision,

perceiving things that are not there (hallucinations), over-excitability, seizures (convulsions), difficulty

breathing, elevated heart rate (tachycardia), accumulation of urine in the 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 stopping 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 and 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 in the 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 symptoms such as abdominal fullness, abdominal pain,

burping, nausea, and 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

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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

Not known (frequency cannot be estimated from the available data)

decreased appetite, high levels of blood potassium which can cause abnormal heart rhythm

increased pressure in the eyes

changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling your heartbeat, 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 not require any 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 of the pack and 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.

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The other ingredients are

Tablet core

Lactose monohydrate, Maize starch, Hypromellose, 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 and 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 5 mg, 10 mg 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 Manufacturer

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 STADA 5 mg, 10 mg, filmom obložene tablete

Urofenacin 5 mg, 10 mg filmtabletta

Solifenacin Clonmel 5 mg, 10 mg film-coated tablets

Solifenacine EG 5 mg, 10 mg comprimé pelliculé

Solifenacin STADA

VESISTAD 5 mg, 10 mg comprimate filmate

Solifenacin STADA 5 mg, 10 mg filmdragerad tablett

Solifenacin STADA 5 mg, 10 mg

Solifenacin 5 mg, 10 mg film-coated tablets

This leaflet was revised in June 2018.