Consumer medicine information

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

• if there is anything you do not understand in this leaflet,
• if you are worried about taking your medicine, or
• to obtain the most up-to-date information.

You can also download the most up-to-date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APO- Dipyridamole/Aspirin Modified Release Capsules.

It contains the active ingredients dipyridamole and aspirin.

This medicine helps prevent recurrence of stroke in people who have had a previous stroke or transient ischaemic attack (TIA).

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

How it works

This medicine works by preventing blood clots from forming. The ability of this medicine to prevent blood clots is due to its effect on blood cells known as platelets.

There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children.

There is limited information about the use of Dipyridamole/Aspirin SR in children.

Before you take this medicine

When you must not take it

Do not take this medicine if:

• You have or have had any of the following:
  - fructose intolerance. Each capsule contains 4.56 mg sucrose resulting in 9.12 mg sucrose per maximum recommended daily dose.
  - severe kidney disease
  - taking the medicine ketorolac
  - more than 6 months pregnant
  - an ulcer of the stomach or intestine, or
  - any condition that increases your risk of bleeding
• You are pregnant.
  Dipyridamole/Aspirin may affect your developing baby if you take it during pregnancy.
• You are breastfeeding.
  The active ingredient in Dipyridamole/Aspirin SR passes into breast milk.
• You are hypersensitive to, or have had an allergic reaction to:
  - dipyridamole
  - aspirin, or NSAIDs, non-steroidal anti-inflammatory medicines
  - or any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms
  If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
• Do not give Dipyridamole/Aspirin SR to children or adolescents with a fever or a viral infection (with or without a fever) except on doctor's advice.
  The aspirin component of this medicine can cause a very rare disease called 'Reye's Syndrome' if given to children or adolescents who have a fever or a viral infection (with or without a fever).
• The expiry date (EXP) printed on the pack has passed.

The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. You have allergies to:
   - any other medicines
   - any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
   - an ulcer of the stomach or intestine
   - any condition that increases your risk of bleeding
   - any heart condition (e.g. angina, heart attack or failure, heart valve problems)
   - severe muscle disease (myasthenia gravis)
   - gallstones
   - asthma
   - hay fever
   - any unusual growth or tumour inside the nose (e.g. nasal polyps)
   - long-term stomach and intestinal problems
   - kidney or liver disease
   - deficiency of the enzyme glucose- 6-phosphate dehydrogenase, which may lead to a condition known as haemolytic anaemia (reduced red blood cells and iron stores)
   If you are uncertain as to whether you have, or have had, any of these conditions you should tell your doctor.
3. You are currently pregnant or you plan to become pregnant.
   Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
4. You are currently breastfeeding or you plan to breast-feed.
   Do not take this medicine whilst breastfeeding.
5. You are taking or are planning to take any other medicines.
   This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop

Taking other medicines

Some medicines may interact with Dipyridamole/Aspirin.

In particular you must tell your doctor if you are taking:

• medicines used to thin your blood such as warfarin.
• medicines used to treat high blood pressure
• neostigmine, distigmine and related medicines (used, for example, to treat myasthenia gravis)
• medicines used to control blood sugar levels
• alcohol
• alendronate
• antacids
• methotrexate
• phenytoin
• spironolactone
• corticosteroids (steroid hormones)
• corticotropin (substances which control the actions of corticosteroids)
• quinidine
• sodium valproate
• diltiazem
• verapamil
• nicotinic acid
• fluoxetine or any other medicines known as selective serotonin reuptake inhibitors or SSRIs (used in the treatment of depression)
• zafirlukast
• aspirin or other NSAIDs (e.g. diclofenac, ibuprofen)
• any medicine that promotes the excretion of uric acid in the urine (eg. probenecid, sulphinpyrazone)
• any medicine which prevents blood cells from clotting (eg. eptifibatide, ticlopidine, clopidogrel, tirofiban)

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with dipyridamole and aspirin.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

The recommended dose for adults is one capsule twice a day.

In some cases you may experience headache when you first start this medicine at the recommended dose.

See your doctor if this occurs.

Your doctor may then change your dose for about one week. The changed dose will be one capsule at bedtime and low dose aspirin (for example, aspirin 75 mg, 100 mg or 150 mg) in the morning. After this time, your doctor will put you back onto your normal dose.

How to take it

Swallow the capsule whole without chewing.

When to take it

Take this medicine at the same time each day, usually one in the morning and one in the evening, and preferably with meals.

Taking it at the same time each day will have the best effect and will also help you remember when to take it.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

This medicine helps control your condition, but does not cure it. Therefore you must take this medicine every day.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of you experiencing side effects.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Signs of overdose may include feeling warm, flushing, sweating, restlessness, dizziness, weakness, rapid breathing, ringing in the ears, nausea, vomiting, vision and hearing disturbances and confusion. There may be effects on the heart and circulation causing chest pain, an increase in heart rate and a drop in blood pressure. In severe overdose, symptoms may include severe mental confusion, shaking, difficulty in breathing, sweating, bleeding, dehydration, reduced body temperature and coma.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

• you are taking any other medicines or are about to be started on a new medicine
  This applies to all medicines obtained with or without a doctor's prescription.
• If you experience a headache or migraine-like headache, especially when you start taking this medicine. Do not treat the headache or migraine-like headache with analgesic doses of aspirin.
• you plan to have 'pharmacological stress testing', surgery or other treatment (even at the dentist).

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

• Give this medicine to anyone else, even if their symptoms seem similar to yours.
• Take your medicine to treat any other condition unless your doctor tells you to.
• Stop taking your medicine, or change the dosage, without first checking with your doctor

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.

This medicine may cause dizziness and confusion in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

• headache or migraine-like headache, especially when you start taking this medicine
• dizziness
• indigestion
• diarrhoea
• nausea
• stomach pain
• vomiting
• inflammation of and wearing of stomach lining
• ulcer of the stomach or intestine
• vomiting blood or material that looks like coffee grounds or bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea
• muscle aches and pains
• hot flushes
• symptoms of low blood pressure (eg. lightheadedness)
• fast heart beat
• skin bruising and blood clots
• bleeding (including nose bleeds, bleeding within the head, bleeding in the eyes or increased bleeding during or after surgery)
• prolonged bleeding time
• anaemia, a condition in which there is a decrease in the number of red blood cells or haemoglobin levels (signs of anaemia include tiredness, being short of breath, dizziness and looking pale)
• iron deficiency anaemia may result from prolonged bleeding
• reduction in blood platelet count (thrombocytopenia), which may result in bruising or bleeding more easily than normal, reddish or purplish blotches under the skin
• worsening of symptoms of heart disease
• fainting

Tell your doctor as soon as possible if you experience any side effect during or after using this medicine, so that these may be properly treated

Allergic reactions

If you think you are having an allergic reaction to this medicine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

You may require urgent medical attention.

Symptoms of an allergic reaction may include some or all of the following:

• cough, shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue, throat or other parts of the body
• rash, itching or hives on the skin
• fainting
• hay fever-like symptoms.

In addition, other side effects not listed above may also occur in some patients.

Tell your doctor or pharmacist if you notice anything unusual, during or after taking this medicine.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Dipyridamole/Aspirin Modified Release Capsules looks like

The gelatin shell of the capsule consists of a red opaque cap and an ivory opaque body.

Available in blister packs of 60 capsules.

Ingredients

Each capsule contains:

• 200 mg of dipyridamole in a sustained-release form and
• 25 mg of aspirin in a standard (immediate) release form.

It also contains the following inactive ingredients:

• tartaric acid
• povidone
• methacrylic acid copolymer (Eudragit S 100)
• talc
• acacia
• hypromellose
• hypromellose phthalate
• simethicone
• cetostearyl alcohol ethoxylate
• sodium benzoate
• triacetin
• stearic acid
• microcrystalline cellulose
• starch pregelatinised
• sucrose
• gelatin
• and the colouring agents:
• titanium dioxide
• iron oxide red (E172) and
• iron oxide yellow (E172).

This medicine is gluten-free, contains sucrose.

Australian Registration Numbers

APO-Dipyridamole/Aspirin SR (HDPE bottle with CR cap):
AUST R 210813.

Sponsor

Apotex Pty Ltd
16 Giffnock Ave
Macquarie Park
NSW 2113
Australia

APO and APOTEX are registered trade marks of Apotex Inc.

This leaflet was last updated in: March 2015

Name of the medicine

Dipyridamole 200 mg, aspirin 25 mg.

Excipients.

Description

Dipyridamole.

Aspirin.

Pharmacology

Pharmacological actions.

Pharmacokinetics.

Absorption.

Distribution.

Metabolism.

Excretion.

Clinical Trials

The second European Stroke Prevention Study (ESPS2) was conducted to investigate the effect of sustained release dipyridamole 200 mg twice daily and low dose aspirin 25 mg twice daily, alone or in combination, for the indications prevention of secondary stroke and transient ischaemic attacks (TIAs). This was a multicentre, multinational, randomised, double blind, placebo controlled trial in patients (n = 6602) who had experienced a recent ischaemic stroke or TIA. There were 4 parallel treatment groups organised in a 2 x 2 factorial design with each treatment given for 2 years. Treatments were: placebo; aspirin 25 mg twice daily; dipyridamole 200 mg sustained release capsule twice daily; and dipyridamole/ aspirin sustained release capsules (dipyridamole 200 mg with aspirin 25 mg) twice daily. The mean age of the patients was 66.7 years. The qualifying event was TIA in 23.7% of patients and stroke in 73.6% of patients.
The three primary endpoints were: stroke (fatal or not); death from any cause; and stroke and/or death occurring within 2 years of inclusion in the study. Secondary endpoints were myocardial infarction, ischaemic events, other vascular events, vascular deaths, vascular events and TIA. Endpoint data were analysed by calculating for each endpoint the survival curves of the four treatment groups. The Cox model was used to identify covariates with significant negative or positive impact upon survival.
In terms of stroke prevention, the results showed highly significant differences between the four survival curves (p < 0.001). Factorial analysis showed that both drugs were effective (p < 0.001), without interaction of one treatment upon the other, and that both given together were additive. Pairwise comparisons demonstrated that the combined therapy with dipyridamole and aspirin resulted in more effective stroke prevention (risk reduction = 37%, p < 0.001, 157/1650) than treatment with either aspirin alone (risk reduction = 18%, p < 0.01, 206/1649) or dipyridamole alone (risk reduction = 16%, p < 0.01, 211/1654), compared to placebo (250/1649). Combined therapy with dipyridamole and aspirin reduced the risk of stroke by 23.1% (p = 0.006) when compared to aspirin therapy alone, and reduced the risk of stroke by 24.7% (p = 0.002) when compared to dipyridamole alone therapy. Subgroup analysis based upon demographic criteria, the type of qualifying event or associated risk factors, corroborated the significant treatment effects observed in the total trial population. Subjects who already had a history of cerebrovascular accidents before the qualifying event, had a greater risk reduction of further stroke with combined therapy (48% [p < 0.001 compared to placebo]) than subjects in which the qualifying event was the first cerebrovascular accident (29% [p < 0.01 compared to placebo]). Subgroup analysis also showed that aspirin and/or dipyridamole were only effective in preventing nonfatal stroke, in contrast to fatal stroke which was not influenced by the treatment. Cox analysis of the survival data identified history of a previous cerebrovascular accident before the qualifying event as the most important risk factor predisposing to stroke recurrence, followed by daily alcohol consumption of > 5 units/day, diabetes and atrial fibrillation. The same analysis showed that receiving dipyridamole or receiving aspirin were strongly protecting against stroke.
Neither aspirin nor dipyridamole influenced mortality significantly. Effects of dipyridamole and/or aspirin on protection from endpoint stroke and/or death were similar to the effects on stroke. In addition to the prevention of stroke, dipyridamole and/or aspirin were effective in preventing subsequent TIAs, especially in the subgroup of patients in whom TIA was the qualifying event. As was observed for stroke, the efficacy of aspirin and dipyridamole when coprescribed was additive, being double that of either drug alone. Other relevant events from which occurrence was modified by treatment included ischaemic events, vascular events, and other vascular events (mostly deep venous thrombosis or peripheral arterial occlusion).
The ESPS2 trial shows the efficacy of both sustained release dipyridamole and low dose aspirin in preventing stroke. Stroke prevention is even more effective when aspirin and dipyridamole are combined, the benefit being additive. The study also shows that such therapy can prevent recurrence of TIA in patients with a previous history of TIA or stroke.
The results of the ESPS2 study are supported by the European/ Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) study that studied a combination treatment of dipyridamole 200 mg twice daily (83% of patients treated with the extended release dipyridamole formulation) and aspirin 30-325 mg daily. A total of 2739 patients who had experienced ischaemic stroke of arterial origin were enrolled in the aspirin alone (n = 1376) and combination aspirin plus dipyridamole (n = 1363) arms. The primary outcome event was the composite of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction, or major bleeding complications, whichever occurred first. In the intention to treat analysis, patients in the aspirin plus dipyridamole group showed a 20% risk reduction (p < 0.05) for the primary composite endpoint compared with those in the aspirin alone group (12.7% [173/1363] versus 15.7% [216/1376]; hazard ratio [HR] 0.80, 95% CI 0.66-0.98).
The PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes) study was a randomised, parallel group, international, double blind, double dummy, active and placebo controlled, 2 x 2 factorial study to compare dipyridamole/ aspirin sustained release capsules with clopidogrel, and telmisartan with matching placebo in the prevention of stroke in patients who had previously experienced an ischaemic stroke, mainly of noncardioembolic origin. A total of 20,332 patients were randomised to dipyridamole/ aspirin sustained release capsules (n = 10,181) or clopidogrel (n = 10,151), both given on a background of standard treatment. For the dipyridamole/ aspirin sustained release capsules versus clopidogrel comparison, the primary objective of the trial was to demonstrate noninferiority of dipyridamole/ aspirin sustained release capsules compared to clopidogrel (noninferiority margin 1.075) on the primary endpoint, which was the time to first recurrent stroke of any type. Hypothesis test was performed using hazard ratios and time to event analyses (Kaplan-Meier). The mean exposure to the antiplatelet medication was 2.0 years in the dipyridamole/ aspirin sustained release capsules group and 2.2 years in the clopidogrel group, reflecting a higher frequency of permanent premature discontinuation of dipyridamole/ aspirin sustained release capsules (35.1%) versus clopidogrel (28.9%). This difference was primarily due to the higher incidence of discontinuations due to adverse events in the dipyridamole/ aspirin sustained release capsules group (16.4%) than in the clopidogrel group (10.7%). Headache, dizziness, vomiting and nausea were the most commonly reported adverse events that contributed to the difference between the two treatment groups (see Adverse Effects).
The incidence of the primary endpoint was similar in both treatment groups (9.0% for dipyridamole/ aspirin sustained release capsules versus 8.8% for clopidogrel; HR 1.01, 95% CI 0.92-1.11). The primary objective of the trial in demonstrating the noninferiority of dipyridamole/ aspirin sustained release capsules versus clopidogrel could not be established and therefore all secondary and tertiary endpoint analysis are considered to be exploratory in nature. For the prespecified secondary composite endpoint of recurrent stroke, myocardial infarction, or death due to vascular causes, similar rates were observed between the dipyridamole/ aspirin sustained release capsules and clopidogrel treatment groups (13.1% in both treatment groups).

Indications

Dipyridamole/Aspirin 200/25 sustained release capsules are indicated for the prevention of recurrent ischaemic stroke and transient ischaemic attacks.

Contraindications

Hypersensitivity to any of the components of the product or salicylates.
Patients with rare hereditary problems of fructose intolerance and/or galactose intolerance (e.g. galactosaemia) should not take this medicine.
Concurrent use with ketorolac.
Severe renal impairment.
Patients with active gastric or duodenal ulcers or bleeding disorders.
Patients in the last trimester of pregnancy.

Precautions

Due to the risk of bleeding, as with other antiplatelet agents, dipyridamole/ aspirin sustained release capsules should be used with caution in patients at increased bleeding risk and patients should be followed carefully for any signs of bleeding, including occult bleeding.
Because dipyridamole is a potent vasodilator, high doses should be used with caution in patients with severe coronary artery disease (e.g. unstable angina or recently sustained myocardial infarction), subvalvular aortic stenosis, or haemodynamic instability (e.g. decompensated heart failure).
Headache or migraine-like headache which may occur especially at the beginning of dipyridamole/ aspirin sustained release capsules therapy should not be treated with analgesic doses of aspirin.
Patients treated with regular oral doses of dipyridamole/ aspirin sustained release capsules should not receive additional intravenous dipyridamole. If pharmacological stress testing with intravenous dipyridamole is considered necessary, drugs containing oral dipyridamole (e.g. dipyridamole/ aspirin sustained release capsules, dipyridamole) should be discontinued for twenty four hours prior to the stress testing. Failure to do so may impair the sensitivity of the test.
In patients with myasthenia gravis, readjustment of therapy may be necessary after changes in dipyridamole dosage (see Interactions with Other Medicines).
A small number of cases have been reported in which unconjugated dipyridamole was shown to be incorporated into gallstones to a variable extent (up to 70% by dry weight of stone). These patients were all elderly, had evidence of ascending cholangitis, and had been treated with oral dipyridamole for a number of years. There is no evidence that dipyridamole was the initiating factor in causing gallstones to form in these patients. It is possible that bacterial deglucuronidation of unconjugated dipyridamole in bile may be the mechanism responsible for the presence of dipyridamole in gallstones.
Due to the aspirin component, dipyridamole/ aspirin sustained release capsules should be used in caution in patients with asthma, allergic rhinitis, nasal polyps, chronic or recurring gastric or duodenal complaints, impaired renal or hepatic function or glucose-6-phosphate dehydrogenase deficiency.
In addition, caution is advised in patients who are hypersensitive to nonsteroidal anti-inflammatory drugs.
There is a possible association between aspirin and Reye's syndrome when given to children. Therefore, dipyridamole/ aspirin sustained release capsules should not be used in children and adolescents with feverish diseases or viral infections with or without fever, because of the risk of Reye's syndrome. Reye's syndrome is a very rare disease, which affects the brain and liver, and can be fatal (see Paediatric use).
Aspirin has been shown to enhance the effect of anticoagulants (e.g. coumarin derivatives and heparin), antiplatelet drugs (e.g. clopidogrel, ticlopidine) and valproic acid which may result in an increased risk of side effects. Selective serotonin reuptake inhibitors (SSRIs) may increase the risk of bleeding. Gastrointestinal side effects also increase when aspirin is administered concomitantly with NSAIDs, corticosteroids or chronic alcohol use.

Effects on fertility.

Use in pregnancy.

Use in lactation.

Paediatric use.

Genotoxicity.

Carcinogenicity.

Effects on ability to drive and use machines.

Effect on laboratory tests.

Investigations.

Interaction with alcohol.

Interactions

When dipyridamole is used in combination with any substances impacting coagulation such as anticoagulants and antiplatelets, the safety profile for these medications must be observed.

Adenosine.

Alcohol.

Alendronate.

Antacids.

Anticoagulants (e.g. coumarin derivatives, heparin).

Antihypertensive agents.

Antiplatelet agents (such as eptifibatide, ticlopidine, clopidogrel, tirofiban).

Cholinesterase inhibitors.

Corticosteroids.

Corticotropin.

Diltiazem.

Ethanol.

Fluoxetine.

Hypoglycaemic agents.

Methotrexate.

Nicotinic acid.

Nonsteroidal anti-inflammatory drugs (NSAIDs).

Phenytoin.

Quinidine.

Selective serotonin reuptake inhibitors (SSRIs).

Sodium valproate.

Spironolactone.

Thrombolytic agents.

Uricosuric agents (e.g. probenecid, sulphinpyrazone).

Verapamil.

Zafirlukast.

Adverse Effects

Clinical trial data.

Blood and lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Eye disorders.

Cardiac disorders.

Vascular disorders.

Respiratory, thoracic and mediastinal disorder.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal, connective tissue and bone disorders.

Investigations.

Injury, poisoning and procedural complications.

Dipyridamole.

Aspirin.

Blood and lymphatic system disorders.

Immune system disorders.

Metabolism and nutritional disorders.

Psychiatric disorders.

Nervous system disorders.

Ear and labyrinth disorders.

Cardiac disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Hepatobiliary disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal, connective tissue and bone disorders.

Renal and urinary disorders.

Pregnancy, puerperium and perinatal conditions.

General disorders and administration site conditions.

Dosage and Administration

The recommended dose is one capsule twice daily, usually one in the morning and one in the evening, preferably with meals.
The capsules should be swallowed whole without chewing.

Alternative regimen in case of intolerable headaches.

Overdosage

Symptoms.

Treatment.

Presentation

Capsules (opaque, red/ivory, sustained release), dipyridamole 200 mg (modified release form) and aspirin 25 mg (standard release form): 60's (white opaque HDPE bottle with child resistant polypropylene closure and containing dessicant, AUST R 210813).

Storage

Store below 25°C. Protect from moisture.

Poison Schedule

S4.