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MOLITA 200MG/25MG MODIFIED-RELEASE CAPSULES HARD

Active substance(s): ACETYLSALICYLIC ACID / DIPYRIDAMOLE / ACETYLSALICYLIC ACID / DIPYRIDAMOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Molita 200 mg/25 mg Modified-Release Capsules, Hard
Dipyridamole and aspirin

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. 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.








In this leaflet
1.
2.
3.
4.
5.
6.

What Molita is and what it is used for
What you need to know before you take Molita
How to take Molita
Possible side effects
How to store Molita
Contents of the pack and other information

1. What Molita is and what it is used for
The name of your medicine is Molita. 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).
Molita belongs to a group of medicines called ‘antithrombotic agents’. They are used to stop blood clots
forming. Molita 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
Molita
Do not take Molita if you:











are allergic to dipyridamole, aspirin or any other
medicines containing aspirin (also called ‘salicylates’)
or 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 ever had abnormal bleeding in the brain
have had stomach pain when previously taking this
medicine
are in the last three months of pregnancy.

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 Molita.

Warnings and precautions

Talk to your doctor or pharmacist before taking Molita
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
heart valve or circulation problems)
• have myasthenia gravis (a rare muscle problem)
• have asthma, hayfever or nasal polyps (a type of
growth in the nose)
• have kidney or liver problems
• need treatment to lower your blood sugar
• have something called ‘glucose-6-phosphate
dehydrogenase deficiency’. This is a problem of the
red blood cells which can cause anaemia
• are in the first six months of pregnancy, likely to get
pregnant or are breast-feeding
• 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
• you regularly drink alcohol.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Molita.

Other medicines and Molita

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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
• medicines for gout






medicines to thin the blood such as warfarin,
heparin, coumarins, clopidogrel, ticlopidine and
anagrelide. 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
other Non-Steroidal Anti-inflammatory Drugs (such
as ibuprofen) for another condition
steroids such as prednisolone
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
adenosine injection - used for heart problems or
tests on the heart
spironolactone - a water tablet
valproic acid - used for the over excited and ‘high’
feeling (manic episodes) that people with bipolar
disorder get
phenytoin - used to treat epilepsy (seizures).

If you are having heart tests

Molita 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
Molita.

Pregnancy and breast-feeding

Do not take Molita if you are in the last three months of
pregnancy. If you are in the first six months of pregnancy,
likely to get pregnant or are breast-feeding, talk to your
doctor before taking this medicine.

Driving and using machines

You may feel dizzy or confused while taking Molita. If this
happens do not drive or use any tools or machines.

Molita 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.
Molita also contains methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216) and colourings
ponceau 4R (E124) and sunset yellow (E110), which may
cause allergic reactions.

3. How to take Molita
Always take this medicine exactly as your doctor 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.
It is best to take it with food.
Swallow the capsule whole with a glass of water.
Do not crush or chew it.

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.

Use in children

This medicine should not be given to children.

If you take more Molita than you should

If you take more of this medicine than you should, talk to a
doctor or go to a hospital straight away. Take the medicine
pack with you, even if there are no capsules left.

If you forget to take Molita

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 Molita

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.

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. The following have been
seen with Molita.

Common (affects less than 1 in 10 people but more than
1 in 100 people)

bleeding in the brain

bleeding in the stomach or gut

nosebleeds
Uncommon (affects less than 1 in 100 people but more
than 1 in 1,000 people)

bleeding in the eye
Unknown (incidence cannot be estimated)

prolonged bleeding from wounds including during or
after surgery or other medical procedures

bruising or swellings where blood has collected
(haematoma)
Allergic reactions
Allergic reactions are common. If you have an allergic
reaction stop taking your medicine and see a doctor
straight away. The signs may include difficulty breathing,
rash which may be severe with itching, or swelling of the
throat or face.

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

5. How to store Molita
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special
temperature storage conditions.
Store in the original package in order to protect from
moisture. Keep the bottle tightly closed.
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.
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.

Other side effects that have been reported for
Molita are:

6. Contents of the pack and other
information

Very Common (affects more than 1 in 10 people)

headache, sometimes migraine. This is more
common at the start of treatment and usually goes
away as treatment continues

feeling dizzy

feeling sick (nausea)

stomach ache

indigestion or diarrhoea

What Molita contains

Common (affects less than 1 in 10 people but more than
1 in 100 people)

anaemia, which may sometimes be due to internal
bleeding into the stomach

worsening of the symptoms of heart disease such as
chest pain and shortness of breath

being sick (vomiting)

muscle pain

fainting
Uncommon (affects less than 1 in 100 people but more
than 1 in 1,000 people)

increased heart beat

lowering of blood pressure

hot flushes

stomach ulcers
Rare (affects less than 1 in 1,000 people but more than 1
in 10,000 people)
• a blood problem called ‘thrombocytopenia’ which can
cause bruising or prolonged bleeding
• inflammation of the stomach
• anaemia due to internal bleeding into the stomach
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 and also apply
to Molita.

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, convulsions (fits) or swelling of the
brain
deafness or ringing in the ears
irregular heart beats
difficulty breathing or fast or shallow breathing
swelling in the throat or excess fluid in the lungs
perforated ulcers in the stomach
blood in the stools or vomiting blood
inflammation of the pancreas
inflammation of the liver (hepatitis)
Reye’s syndrome – a rare disease which can be fatal
especially if aspirin is given to children
rash with blisters
muscle breakdown
kidney failure and other kidney problems
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)

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.

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, hypromellose
phthalate, dimethicone, triacetin, stearic acid; Aspirin
tablet – microcrystalline cellulose, anhydrous lactose, corn
starch, colloidal anhydrous silica, stearic acid, polyvinyl
alcohol, titanium dioxide, talc, quinoline yellow (E104),
soya lecithin (E322), xanthan gum (E415); Capsule shells
– gelatine, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), ponceau 4R (E124), patent
blue (E131), quinoline yellow (E104), sunset yellow
(E110), titanium dioxide (E171).

What Molita looks like and contents of the pack

Capsule (size 0xEL) with orange coloured cap and white
to off-white coloured body.
Molita is available in plastic bottles with child-proof closure
containing 30, 50, 60 (1 x 60), 60 (2x30) or 100 (2 x 50)
capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, HU17 0LD, United Kingdom
This leaflet was last revised in 02/2017

Expand Transcript

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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