BETIM 10MG TABLETS

Active substance: TIMOLOL MALEATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PATIENT INFORMATION LEAFLET

Betim® 10 mg Tablets
Timolol maleate

Please read all of this leaflet carefully before you
start taking this medicine.
■ Keep this leaflet.You may need to read it again.
■ f you have any further questions, ask your
I
doctor or pharmacist.
■ 
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
■  f you get any side effects, talk to your doctor or
I
pharmacist. This includes any possible side effects
not listed in this leaflet.
In this leaflet:
1. What Betim is and what it is used for
2. What you need to know before you take Betim
3. How to take Betim
4. Possible side effects
5. How to store Betim
6. Contents of the pack and other information
1. WHAT BETIM IS AND WHAT IT IS USED FOR
Betim 10 mg Tablets are used to treat high blood
pres­ ure (hypertension) and chest pain (angina).
s
The tablets are also used to prevent a heart attack
in those people who have already had one and in
reducing the number of migraine attacks for those
who suffer from migraine.
Betim Tablets belong to a group of medicines called
beta-blockers which slow the heart rate and lower
blood pressure, reducing the workload on the heart.
2.  HAT YOU NEED TO KNOW BEFORE YOU
W
TAKE BETIM
Do not take Betim if you:
■  allergic (hypersensitive) to timolol maleate or
Are
any of the other ingredients of Betim (these are
listed in section 6, “Contents of the pack and other
information”).
■ 
Have a history of wheezing or asthma.
■ 
Have chronic (long-term) breathing difficulties.
■ Have a certain type of chest pain called Prinzmetal’s
angina.
■ 
Have uncontrolled heart failure.
■ 
Have been told that you have a slower than normal
heart beat or a severe heart condition called
cardiogenic shock.
■ 
Have any problems with your blood circulation.
■ Are taking medicines known as monoamine oxidase
inhibitors that are used for depression.
■  ave a condition affecting your adrenal glands
H
called phaeochromocytoma.
■ 
Have a condition that causes acidity of the blood
called metabolic acidosis.
■ 
Have low blood pressure.
Warnings and Precautions
Tell your doctor before you start treatment if you have
or have had in the past one of the following problems
or if you develop any of these during treatment:
■ 
Any heart problems at all, including an abnormally
slow heart rate.
■ 
Liver or kidney problems.
■ 
Diabetes. Betim may mask some of the usual signs
that your blood sugar level is too low.
 you are on medication for diabetes, Betim could
If
also increase the effectiveness of insulin or oral antidiabetic drugs so your dose of these may need to be
changed.
■  skin condition psoriasis.
The
■ 
Poor circulation in your legs or arms.
1013_GI_Betim_UK_Sonder_56UK2037131-00.indd 1

■  ny allergies (e.g. to pollen),
A
as Betim may intensify your
allergic reaction.
It is important to discuss these
with your doctor because you may
need to stop your treatment or
have your dose changed.
Children
Betim 10 mg Tablets are not suitable
for children.
Other medicines and Betim
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription. This is
very important because you should not use some
other medicines while you are taking Betim. Also,
certain other medicines can be used only if special
precautions are taken.
In particular, tell your doctor or pharmacist if you are
taking:
■ ny medicines for high blood pressure (e.g.
A
clonidine or hydralazine).
■ 
Other medicines for heart problems (e.g. verapamil,
disopyramide, lignocaine, tocainide, diltiazem,
quinidine, amiodarone, nifedipine, digitalis
glycosides (e.g. digoxin), or any of the medicines
known as class I antiarrhythmic agents).
■ Other beta-blockers.
■  edicines known as tricyclic antidepressants
M
used for treating depression, or medicines known
as phenothiazines used for treating other mental
problems.
■  edicines known as barbiturates used to treat
M
sleeping disorders.
■ 
Medicines for treating diabetes (e.g. insulin and
oral anti-diabetic drugs).
■  anti-ulcer drug called cimetidine.
An
■  antibiotic called rifampicin.
An
■ 
Medicines to improve circulation.
■ Medicines for breathing difficulties (e.g. salbutamol
or isoprenaline).
■ 
Medicines for migraine known as ergot preparations.
■  edicines known as prostaglandin synthetase
M
inhibitors (e.g. ibuprofen, aspirin, indomethacin).
If you are going to have surgery
If you are going to have an operation in hospital
or going to the dentist, tell the doctor at the hospital
or the dentist that you are taking Betim Tablets. Your
doctor may decide to stop Betim gradually before
you have an anaesthetic such as ether, cyclopropane,
trichloroethylene. You should not be given a local
anaesthetic combined with adrenaline while you are
taking Betim.
Taking Betim with food and drink
You should avoid excessive alcohol consumption
while taking Betim.
Pregnancy and breast-feeding
You should not take Betim if you are pregnant.
Therefore, tell your doctor before you start treatment
if you are pregnant, think that you may be pregnant or
intend to become pregnant.
Consult with your doctor immediately if you think
that you have become pregnant during treatment
with Betim.
Tell your doctor before you start treatment with Betim
if you are breast-feeding or planning to breastfeed.

18.11.13 16:41

Driving and using machines
This medicine may cause tiredness or dizziness as a
side effect.
Therefore you should be careful if you are going to
drive or operate machinery.

■ 
Unusual tiredness or weakness.
■  ecreased urination or total
D
inability to urinate.

3. HOW TO TAKE BETIM

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 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.

Your doctor will work out the right number of tablets
for you. Always take Betim exactly as your doctor
has told you.You should check with your doctor or
pharmacist if you are not sure.
Swallow the tablet(s) with a glass of water.
The usual dose for adults is:
■ 
Half a tablet to three tablets twice a day for chest
pains.
■ 
One to six tablets a day for high blood pressure.
■ 
Half a tablet to one tablet twice a day after a heart
attack.
■  ne to two tablets a day to prevent migraine attacks.
O
The tablet can be divided into equal doses.
If you are elderly the doctor will probably start with the
lowest adult dose and then adjust your dose carefully,
depending on how you respond to treatment.
Betim Tablets are not suitable for children.
Your doctor may change the number of tablets you
take. This will depend on how well you respond to the
treatment. Do not alter the number of tablets you are
taking without checking with your doctor.
If you take more Betim than you should
If you or anybody else accidentally take more than the
recommended dose of these tablets, call your doctor
immediately or go to your nearest hospital casualty
department.
If you forget to take Betim
If you forget to take your tablet(s), take the next dose
as normal.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Betim
Do not stop taking the tablets without first consulting
your doctor.
If it is right for you to stop taking the medicine then
your doctor will probably reduce the dose gradually
since it is important not to stop suddenly.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Betim can cause side effects,
although not everybody gets them.
Tell your doctor if you have any of the following
problems:
■ 
Breathing difficulties or a worsening of asthma.
■ Slow heart beat or the heart slows so much that you
faint, heart failure or other heart problems.
■ 
Cold or bluish hands and feet, low blood pressure,
“pins and needles”, tingling in the hands or feet, a
worsening of any problems with blood circulation
in your legs or impotence (male erection problems).
■ ausea (feeling sick), vomiting (being sick),
N
diarrhoea or abdominal pain.
■ 
Dizziness or light headedness, vertigo or feeling
faint, headaches, trouble with sleeping or nightmares.
■ 
Depression, hallucinations, drowsiness, disorientation,
confusion or other mental problems.
■ 
Skin rashes, painful joints, visual disturbances or
dry eyes.

1013_GI_Betim_UK_Sonder_56UK2037131-00.indd 2

Blood tests may show increased
levels of antibodies.

5. HOW TO STORE BETIM
Keep Betim Tablets out of the reach and sight of
children.
Do not use Betim after the expiry date which is stated
on the bottle label and outer carton after the text
“EXP”. The expiry date refers to the last day of that
month.
This medicine requires no special storage conditions.
Medicines must not be disposed of via wastewater or
household waste.
Ask your pharmacist how to dispose of medicines no
longer required.
These measures will help to protect the environment.
6.  ONTENTS OF THE PACK AND OTHER
C
INFORMATION
What Betim contains
Active substance: 
Timolol (as maleate). Each
tablet contains 10 mg of timolol
maleate.
Other ingredients:  icrocrystalline cellulose, pregeM
latinised starch and magnesium
stearate.
What Betim looks like and contents of the pack
Betim Tablets are white, flat circular tablets. Each tablet
V
is engraved with “ BET ” on one side and a breakmark
on the other.
The tablets are supplied in amber glass bottles, or packs
containing aluminium blister strips, of 30 or 100 tablets.
Not all packs sizes may be marketed.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd.,
Skyway House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK
Manufacturer
Labiana Pharmaceuticals S.L.U., Casanova 27-31,
08757- Corbera de Llobregat (Barcelona), Spain.
For any information about this medicine, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 11/2013.

If this leaflet is difficult to
see or read, or you would like it in
a different format, please contact
Meda Pharmaceuticals Ltd.,
Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford,
CM22 6PU, UK

34830E0EU-E00
56UK2037131-00

18.11.13 16:41

Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85    
· Fax: -87    
· E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet      mock-up
MANUFACTURER: Meda Pharma GmbH & Co. KG

COLOURS USED:

PRODUCT:
Betim 10 mg


Black

Tablets

MEDA-NO.: 56UK2037131-00
ITEM-CODE: 34830E0EU-E00
PHARMA-CODE: 30E0EUE
COUNTRY:

United Kingdom

LANGUAGE: English
PACK SIZE:

135 x 260 mm

CORRECTION: 4.

FONT SIZE:

8 pt/ 9,5 pt

DATE:

1013_GI_Betim_UK_Sonder_56UK2037131-00.indd 3

18. 11. 2013

18.11.13 16:41

Expand view ⇕

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.

Hide
(web1)