Package leaflet: Information for the user

Atenolol 5mg/ml Oral Solution

PIL/UK/MFG105/04/v1 TURN OVER

1

becinfo

The5mgrefeleaf

Wh1.

2.

3.4.5.6.

Ateatenmedis u

It wmor

2

. What Ateis used fo

Read alcarefultaking t

cause it contormation for

Keep this leread it agaiIf you haveask your doThis medicinfor you onlyothers. It mtheir signs oas yours. If you get ayour doctorincludes anynot listed insection 4.

e name of theg/ml Oral Soluerred to as Ateflet.

hat is in this What Atenused for What you nyou take AHow to takPossible siHow to stoContents oinformatio

nolol containsnolol. This beldicines calledsed to:

Treat high b(hypertensioTreat uneve(arrhythmiaHelp prevenProtect the treatment a(myocardial

orks by makire slowly and

. What yobefore y

enolol is andor

ll of this leafly before youthis medicintains importar you.

aflet. You man.any further qctor, or pharme has been p. Do not passay harm themf illness are t

ny side effector pharmacis possible side this leaflet. S

medicine is Aution but will enolol through

leaflet: nolol is and w

need to knowAtenolol ke Atenolol ide effects ore Atenololof the pack aon

s the active sulongs to a grobeta-blockers

lood pressureon). en heart beatsas). t chest pain (heart in the e

after a heart al infarction). ng your heartwith less forc

u need to knou take Aten

what it

flet u start e

ant

y need to

uestions, acist.

rescribed it on to even if

he same

s, talk to st. This

effects ee

tenolol behout this

what it is

w before

nd other

ubstanceoup of s. Atenolol

e

s

(angina). early attack

t beat ce.

-

-

-

Do not taYou are allergthe other ingr(listed in SectYou have evefollowing hea

heart failucontrol (thbreathlessankles to second- oblock (a ctreated byvery slowbeats, ververy poor

ake Atenololgic to Atenololredients of Atetion 6). r had any of trt problems:

re which is nois usually ma and causes yswell). r third-degreeondition whichy a pacemakeor very uneve

ry low blood pcirculation.

l if: l or any of enolol

the

ot under akes you your

e heart may be

r).en heart

pressure or

You have a tuphaeochromobeing treated

umour called ocytoma that i. This is usua

is not lly near

now nolol

Disopyamiodbeat).

yramide, quindarone (for an.

nidine or n uneven hearrt

your kidblood ptreatedyour domedicintake asYou havhigher tyour blo

Do not takeapply to yoyour doctorAtenolol.

WarningsTalk to youtaking Aten You h

any oproblreactstingasthmtake tcheck

You h(anginangina

You hcontro

You h You h

may chavingfeel yo

You hconditthyroihide tthyrot

You hkidneysometreatm

If you are napply to yopharmacist

A

Tell your dotaking, or hother medithat you buherbal medAtenolol camedicines whave an eff

In particulapharmacistfollowing m Clonid

or migclonidnot styour dyou hyour dinstru

Verap(for hpain).

ney and canressure. If yofor phaeochro

octor will givene, called an a

well as Atenove been told tthan normal leood (metaboli

e Atenolol if aou. If you are r or pharmaci

and precautr doctor or ph

nolol if: have asthmaother similarlems, or youtions, for exas. If you hav

ma or wheezthis medicinking with yoave a type ofna) called Prina.ave poor blooolled heart faiave first-degrave diabetes.change how yog low blood suour heart beaave thyrotoxiction caused byid gland). Youthe symptomstoxicosis. ave problemsys. You may ncheck-ups du

ment.

not sure if anyou, talk to yout before taking

Other medicAtenolol

octor or pharmhave recentlycines. This incuy without a pdicines. This isn affect the work and som

fect on Atenol

ar, tell your dot if you are takedicines:

ine (for highraine). If youine and Ateno

top taking clonoctor tells yo

ave to stop taoctor will giv

ctions about hamil, diltiazemigh blood pres

cause high u are being omocytoma, you another

alpha-blocker,olol. hat you haveevels of acid ic acidosis).

ny of the abonot sure, talkst before taki

tions armacist befo

a, wheezing or breathing

get allergicample to inseve ever had zing, do not ne without firur doctor. chest pain

nzmetal’s

od circulation olure. ree heart bloc Your medicinou respond tougar. You mayting faster. cosis (a y an overactivur medicine ms of

s with your need to have uring your

y of the aboveur doctor or g Atenolol.

cines and

acist if you ataken, any cludes medicinrescription an

s because ay some othee medicines col.

octor or ing any of th

blood pressur are taking lol together,idine unless

ou to do so. Ifking clonidinee you carefulow to do it. and nifedip

ssure or chest

to

n

vek to ng

ore

or

ect

rst

or

k.neoy

veay

e

are

nesnd

ercan

he

re

do

e,

ine t

OperIf youoperamediAtenolow bare gare ta

AtenAtenofood.

Talk tAtenobecom

Drivi Yo

yotobemth

Ifthan

(E21paracausedelaySorb(E42doctosometakinThis mmmo(20mconsisodiu

Digoxin (for hAdrenaline, aepinephrine (stimulates thIbuprofen or and inflammaInsulin or meby mouth forMedicines to congestion or(including thopharmacy).

rations u go into hospation, tell thecal staff that yolol. This is belood pressureiven certain aaking Atenolo

nolol with fooolol should no

to your doctoolol if you areme pregnant o

ing and usinour medicine ou being ableools or machinest to wait to

medicine affecthese activities you feel dizz

his medicine, ny tools or ma

Atenolol cThis medicparahydr

18) and prophydroxybenze allergic reacyed).bitol liquid (n20): If you haor that you hae sugars, contg this medicin

edicinal prol (or 55.89 ml Atenolol). Toderation by p

um diet.

eart problemlso known asa medicine the heart). indometacin (tion). dicines that ydiabetes.treat nose or other cold rese you can b

ital to have aanaesthetist oou are takingcause you ca (hypotensionnaesthetics wl.

odot be taken wit

r before takinpregnant, ma

or are breast-

g machinesis not likely toto drive or us

nes. However,see how your

ts you before s.y or tired whedo not drive oachines.

contains: cine contains roxybenzoateylzoate (E216

ctions (possibl

non-crystallisve been told b

ave an intoleraact your doctoal product.

duct containsg) sodium peo be taken intatients on a c

s).

hat

(for pain

ou take

sinus medies uy in the

nr

n get ) if you hile you

th the

gay-feeding.

o affect se any , it is rtrying

en taking or use

methyl e

): May y

sing) by your ance to or before

2.43 er dose tocontrolled

Alwaydoctowith yare n

3.

ys take Atenoor has told youyour doctor o

not sure. Your doctor wsolution to tato take it. Recarton to remdoctor said. Atenolol shouTry to take yosame time ea

How to ta

olol exactly as. You should

r pharmacist

ill tell you hoke each day aad the label oind you what

ld be swallowour medicine ch day.

ke Atenolol

yourcheck

if you

ow much nd when n the

t the

ed.at the

Pregnancybreast-feed

and ding

Adults High blood pressure

(hypertension): The usual initial dose is 5ml (25mg) per day. The usual maintenance dose is once daily 10 to 20ml (50 to 100mg).

Chest pain (angina): The usual dose is 10 to 20ml (50 to 100mg) per day. The dose of 20ml (100mg) per day can be divided over two doses per day.

Uneven heart beats (arrhythmias):the usual dose is 10ml (50mg) to 20ml (100mg) once daily.

The early treatment of a heart attack (myocardial infarction): the usual dose is 10ml (50mg) to 20ml (100mg) a day.

Elderly people If you are an elderly person, your doctor may decide to give you a lower dose, particularly if you have problems with your kidneys.

People with kidney problems If you have severe kidney problems your doctor may decide to give you a lower dose.

Children Your medicine must not be given to children.

Route and method of administration This medicinal product must be taken orally. Use the double ended plastic spoon (as shown below) to measure the required dose. The smaller end measures 2.5ml and larger end measures 5ml.

If you take more Atenolol than you should If you take more Atenolol than prescribed by your doctor, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so that the medicine can be identified.

If you forget to take Atenolol If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atenolol Do not stop taking Atenolol without talking to your doctor. In some cases, you may need to stop taking it gradually.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions: If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat.

See your doctor as soon as possible if you get any of the following side effects:

4. Possible side effects

Jaundice (causing yellowing of your skin or the whites of your eyes).

You may become more prone to bruising or bleeding or have purplish marks on your skin – this could be a sign of changes to some of the cells or other parts of your blood and your doctor may want to take blood samples every so often to check this.

Other possible side effects: Common (affects less than 1 in 10 people) You may notice that your pulse

rate becomes slower while you are taking the medicine. This is normal, but if you are concerned please tells your doctor about it.

Cold hands and feet. Diarrhoea. Feeling sick (nausea). Feeling tired.

Uncommon (affects less than 1 in 100 people) Disturbed sleep.

Rare (affects less than 1 in 1,000 people) Heart block (which can cause

dizziness, abnormal heart beat, tiredness or fainting).

Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud’s disease).

Mood changes. Nightmares. Feeling confused. Changes in personality

(psychoses). Hallucinations. Headache. Dizziness (particularly when

standing up). Tingling of your hands. Being unable to get an erection

(impotence). Dry mouth. Dry eyes. Disturbances of vision. Thinning of your hair. Skin rash.

Lupus-like syndrome (a diseasewhere the immune system producesantibodies that attacks mainly skinand joints).

Conditions that may get worse If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely affecting less than 1 in 1,000 people. Psoriasis (a skin condition). Being short of breath or having

swollen ankles (if you have heart failure).

Asthma or breathing problems. Poor circulation.

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.

Not known (frequency cannot beestimated from the available data)

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atenolol

Keep out of the sight and reach of children.

Do not use after the expiry date which is stated on the carton or bottle after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 25°C. For 100ml and 150ml: Discard 30

days after first opening. For 300ml: Discard 60 days after

first opening. Do not throw away any medicine via

waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

What Atenolol contains The active substance is Atenolol.

6. Contents of the pack and other information

Each ml of oral solution contains 5mg Atenolol. The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate (E330), sodium citrate (E331), sorbitol liquid (non-crystallising) (E420), saccharin sodium (E954), orange flavor [containing propylene glycol (E1520)] and purified water.

What Atenolol looks like and contents of the pack Atenolol is clear colourless oral solution with orange flavour supplied in an amber PET bottle with tamper-evident child resistant plastic cap and a double-ended plastic spoon for measuring and administering the dose.

Atenolol is supplied in bottles containing 100ml, 150ml and 300ml solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: Syri Limited t/a Thame Laboratories Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

The medicinal product is authorised in the Member states of the EEA under the following names:

UK and IE: Atenolol 5mg/ml Oral Solution

POM

This leaflet was last revised in 09/2015.

PIL/UK/MFG105/04/v1