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SVELUX 200MG/25MG MODIFIED RELEASE CAPSULES HARD

Active substance(s): ACETYLSALICYLIC ACID / DIPYRIDAMOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Svelux 200 mg/25 mg Modified-release Capsules, hard
dipyridamole and aspirin

Children and adolescents
Svelux should not be given to children and adolescents.

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.

Other medicines and Svelux
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes herbal medicines. This is because Svelux can
affect the way some other medicines work. Also some
other medicines can affect the way Svelux works.

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• aspirin or medicines containing aspirin (or planning to
for any condition)
• medicines for high blood pressure. The blood pressure
lowing effects of these medicines could be increased
• medicines to thin the blood such as warfarin, heparin,
coumarins, clopidogrel and ticlopidine. The effect of
these medicines could be increased, increasing the risk
of bleeding. If you attend an anticoagulant clinic tell
them at your next visit
• medicines for depression called ‘selective serotonin
reuptake inhibitors’ such as fluoxetine, paroxetine or
sertraline. The risk of bleeding could be increased
• other Non-Steroidal Anti-inflammatory Drugs (such
as ibuprofen) for another condition , or steroids (such
as prednisolone). The risk of side effects of your
stomach and intestines could be increased
• methotrexate - used for joint problems or cancer. The
risk of side effects may be increased. Your doctor may
want to do some blood tests. Do not take this medicine
if your dose of methotrexate is higher than 15 mg/week
• medicines to lower your blood sugar. The effect of
these medicines may be increased
• adenosine - used for heart problems or tests on the
heart. Your doctor may want to change the amount of
adenosine you are taking
• spironolactone - a water tablet. The effect of this
medicine may be reduced
• uricosuric medicines used to treat gout, such as
probenecid or sulphinpyrazone. The effect of these
medicines may be reduced
• valproic acid - used for treating epilepsy or during the
manic episodes) in people with bipolar disorder. The risk
of side effects could be increased
• phenytoin - used to treat epilepsy (seizures). The risk
of side effects could be increased
• cholinesterase inhibitors. The effect of these
medicines could be reduced leading to a worsening of
myasthenia gravis.

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

1. What Svelux is and what it is used for
The name of your medicine is Svelux. It contains two
different medicines called dipyridamole and aspirin. Both
belong to a group of medicines called ‘anti-thrombotic
medicines’. Aspirin is also a type of medicine called a
‘Non-Steroidal Anti-inflammatory Drug’ (NSAID).

Svelux belongs to a group of medicines called
‘anti-thrombotic agents’. They are used to stop blood clots
forming. Svelux is used for people who have had a
• Stroke
• Transient Ischaemic Attack (TIA)
which are caused by a clot in the brain. This medicine
reduces the risk of them happening again.

2. What you need to know before you take
Svelux

Do not take Svelux if you:
• are allergic to dipyridamole, aspirin or any other
medicines containing substances similar to aspirin (also
called ‘salicylates’) or to any of the other ingredients of
this medicine (listed in section 6: )
• are allergic to peanut or soya
• have any bleeding problems
• have ever had an ulcer in your stomach or gut
(duodenum)
• have severe kidney or liver problems
• are taking methotrexate at doses higher than 15 mg/week
• have something called ‘glucose-6-phosphate
dehydrogenase deficiency’. This is a problem of the
red blood cells which can cause anaemia
• have ever had abnormal bleeding in the brain
• have had stomach pain when previously taking this
medicine.

If you are having heart tests
Svelux contains dipyridamole. Dipyridamole is also
sometimes given as an injection during tests to see if the
heart is working properly (also called ‘myocardial imaging’).
This means that the test and your medicine may contain
the same substance. If you are going to have an injection
of dipyridamole, tell the doctor that you are taking Svelux.

Svelux with alcohol
Do not take Svelux capsules at the same time as an
alcoholic drink. Avoid drinking excessive amount of alcohol
because the risk of side effects to your stomach and
intestines could be increased.

Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Svelux.

Warnings and precautions
Talk to your doctor or pharmacist before taking svelux if you:
• have an increased risk of bleeding as you might
require careful follow up by your doctor
• have angina or other heart problems (including a
recent heart attack, heart failure, heart valve or
circulation problems), as this medicine can cause
widening of your blood vessels
• have myasthenia gravis (a rare muscle problem). The
dose of medicine you take for myasthenia gravis may
need to be adjusted, especially when the dose of Svelux
is changed
• have asthma, hay fever or nasal polyps (a type of
growth in the nose)
• have kidney or liver problems. If these are severe, do
not take this medicine
• are allergic to Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs) such as ibuprofen
• are taking medicines that increase the risk of
bleeding such as anti-platelet medicines (e.g.
clopidogrel) or some antidepressants (SSRIs e.g.
paroxetine, sertraline, fluoxetine)
• have long-term or recurring stomach or intestine
problems, causing your stools to be darker in colour
• are about to have surgery such as having a tooth
removed. Your doctor may want you to stop taking this
medicine up to 7 days before.

If you get a severe migraine-like headache at the start of
your treatment tell your doctor. DO NOT take painkillers
containing aspirin to treat your headache.

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Svelux.

Pregnancy and breast-feeding
Svelux is not recommended during 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.

Driving and using machines
Svelux is not likely to affect your ability to drive or use
machines.

Svelux contains lactose.
If you have been told by your doctor that you have an
intolerance to some sugars (e.g. lactose), contact your
doctor before taking this medicine.

Svelux contains parahydroxybenzoate
Svelux contains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216), which may cause
allergic reactions (possibly delayed).

Svelux contains the colouring ponceau 4R (E124) and
sunset yellow (E110)
May cause allergic reactions.

3. How to take Svelux
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is
• One capsule twice a day usually one in the morning and
one in the evening.

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• lowering of blood pressure
• hot flushes

• Swallow the capsule whole with a glass of water.
• Do not crush or chew it.

Rare, may affect up to 1 in 1,000 people
• inflammation of the stomach

If you get a severe migraine-like headache at the start of
your treatment tell your doctor as they may need to change
your dose for a short period of time. DO NOT take
painkillers containing aspirin to treat your headache.

In addition, there are other side effects that are known for
the active ingredients dipyridamole and aspirin when
taken on their own. These are listed below. However they
have not been reported for Svelux.

Use in children and adolescents
This medicine should not be given to children and
adolescents (see also section 2 “Warnings and precautions”).

Dipyridamole
In people who have gallstones, dipyridamole can be
absorbed into the gallstones.
Aspirin
• blood clotting problems and bleeding gums
• severe allergic reactions especially in patients who have
asthma
• high or low blood sugar levels
• increased uric acid in the blood, which may cause gout,
or other changes in the composition of the blood
• feeling thirsty or becoming dehydrated
• feeling confused or restless
• feeling less alert
• irregular heart beats
• difficulty breathing or fast or shallow breathing
• excess fluid in the lungs
• rash with blisters
• possible effect on liver test results
• prolonged pregnancy or labour, bleeding before or after
birth, small baby or stillbirth
• fever or low body temperature (hypothermia)

If you take more Svelux than you should
If you take more of this medicine than you should, talk to a
doctor or go to a hospital straight away. You may
experience symptoms of dizziness, confusion, tinnitus
(ringing in your ears), breathing too fast, feeling sick, being
sick, loss of hearing, warm feeling, flushing of the face,
sweating, restlessness, weakness or heart problems. Take
the medicine pack with you, even if there are no capsules left.

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

If you stop taking Svelux
Do not stop treatment without talking to your doctor first.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine.

Bleeding
Bleeding at different sites within the body can occur which
in some cases may be serious.
In such cases stop taking your medicine and seek
urgent medical advice.

5. How to store Svelux
Keep this medicine out of the sight and reach of children.

If you have any of the following side effects, stop
taking your medicine and see a doctor straight away.

Store in the original package in order to protect from
moisture. Keep the bottle tightly closed.

Common, may affect up to 1 in 10 people
• allergic reactions. The signs may include difficulty
breathing, rash of the skin which may be severe with
itching, or swelling of the throat or face.
• bleeding in the brain
• bleeding in the stomach or gut
• nosebleeds

This medicine does not require any special temperature
storage conditions.

Do not use this medicine after the expiry date which is
stated on the carton and the bottle label. The expiry date
refers to the last day of that month.

Do not open the bottle until you are ready to start taking
the capsules. If you have any capsules left in the bottle
after 30 days, these should not be taken.

Uncommon, may affect up to 1 in 100 people
• bleeding in the eye
• stomach ulcers. Signs may be continuous heartburn,
black tarry stools, abdominal discomfort.

Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.

Rare, may affect up to 1 in 1,000 people
• reduction in blood platelets, which increases risk of
bleeding or bruising (thrombocytopenia)
• anaemia due to internal bleeding into the stomach

Frequency not known, frequency cannot be estimated
from the available data
• prolonged bleeding from wounds including during or
after surgery or other medical procedures, skin bleeding
• bruising or swellings where blood has collected
(haematoma)
• blood in the stools or vomiting blood
• inflammation of the pancreas, which causes severe pain
in the abdomen and back
• inflammation of the liver (hepatitis)
• abnormal muscle breakdown which can lead to kidney
problems (rhabdomyolysis)
• kidney failure and other kidney problems
• convulsions (fits) or swelling of the brain
• deafness or ringing in the ears
• Reye’s syndrome, a rare disease which affects major
organs and can be fatal. It especially occurs if
acetylsalicylic acid* is given to children.
• swelling in the throat

Other side effects that have been reported for Svelux

Very common, may affect more than 1 in 10 people
• headache. This is more common at the start of
treatment and usually goes away as treatment
continues. If this occurs, tell your doctor. DO NOT take
painkillers containing aspirin to treat your headache
• feeling dizzy
• feeling sick (nausea)
• stomach ache
• indigestion or diarrhoea

6. Contents of the pack and other
information
What Svelux contains
• The active substances are dipyridamole and aspirin.
Each capsule contains dipyridamole 200 mg in modified
release form and 25 mg aspirin in standard release form.

• The other ingredients are: Dipyridamole pellets – tartaric
acid, hypromellose, acacia, talc, povidone, methacrylic
acid-methyl methacrylate copolymer (1:2), hypromellose
phthalate, dimethicone 350, triacetin, stearic acid;
Aspirin tablet – microcrystalline cellulose, lactose
anhydrous, pre-gelatinised corn starch, colloidal
anhydrous silica, stearic acid, polyvinyl alcohol-part
hydrolysed, titanium dioxide (E171), talc, quinoline
yellow aluminium lake (E104), soya lecithin (E322),
xanthan gum (E415); Capsule shells – gelatine, methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ponceau 4R (E124),
patent blue V (E131), quinoline yellow (E104), sunset
yellow (E110), titanium dioxide (E171);

What Svelux looks like and contents of the pack
The capsules have an orange cap and white to off-white
body.

Svelux 200 mg/25 mg modified-release capsules, hard is
available in bottles containing 30, 50, 60 (2x30) and 100
(2x50) capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Common, may affect up to 1 in 10 people
• reduction in red blood cells which can make the skin
pale and cause weakness or breathlessness (anaemia)
• worsening of the symptoms of heart disease
• migraine
• being sick (vomiting)
• muscle pain
• fainting

Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, UK.

This leaflet was last revised in 01/2016.

Uncommon, may affect up to 1 in 100 people
• faster heart beat

SZ00000LT000

Artwork Proof Box
Ref: V009: Safety update (SPC, PIL and Labelling) + RFI
Proof no.
003.3

Date prepared:
12/01/2016

Colours:
Black
White
Dimensions: 150 x 360 mm

Font size:
7.63 pt
Fonts:
Arial Narrow

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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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