dispersible aspirin 75 mg tablets - gov.uk aspirin 75 mg tablets are available in blister packs of...

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PAGE 1: FRONT FACE (INSIDE OF REEL) Top of page cut-off to middle of registration mark: 44 mm. Pharma code 2156 In this leaflet: 1. What Dispersible Aspirin 75 mg Tablets are and what they are used for? 2. What you need to know before you take Dispersible Aspirin 75 mg Tablets 3. How to take Dispersible Aspirin 75 mg Tablets 4. Possible side effects 5. How to store Dispersible Aspirin 75 mg Tablets 6. Contents of the pack and other information 1. WHAT DISPERSIBLE ASPIRIN 75 MG TABLETS ARE AND WHAT THEY ARE USED FOR? These tablets contain Aspirin (acetylsalicylic acid) which belongs to a group of medicines known as antiplatelet agents. Platelets are cells in the blood that cause the blood to clot. An antiplatelet agent helps to prevent blood clotting. Dispersible Aspirin 75mg Tablets is used to help prevent further heart disease such as heart attacks (myocardial infarctions) or strokes in people who have previously suffered these conditions or who have under gone by-pass surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISPERSIBLE ASPIRIN 75 MG TABLETS Before starting long term use of Aspirin you must consult your doctor who will discuss the benefits and risks of this therapy with you. Do not take these tablets if you: Are allergic (hypersensitive) to Aspirin, any other salicylates or any of the other ingredients of this medicine (listed in section 6). Have a stomach or duodenal ulcer or have had problems with ulcers in the past. Suffer from haemophilia or any other excessive bleeding condition. Suffer from gout. Are taking blood thinning (anti-coagulant) medication. Have a history of hypersensitivity reactions (eg asthma, rhinitis, urticaria) induced by pain relieving or anti-inflammatory medicines (eg NSAIDs or salicylates). Have severe liver or kidney problems. Have asthma or have ever had it in the past or suffer from tightness in the chest. Are on a high dose of methotrexate (15mg per week or more). If you are not sure, check with your doctor. Also see section ‘Using other medicines.’ Are in the last 3 months of pregnancy or are breast feeding, unless advised by a doctor. Warning and precautions: Take special care and tell your doctor before taking Dispersible Aspirin 75 mg tablets if you: Are suffering from dehydration (feeling constantly thirsty) Have been told you are deficient in glucose-6-phosphate dehydrogenase (G6PD), as you may experience anaemia. Are taking this product for the first time. Your doctor will be able to advise on the relative benefits and risks of long-term treatment with aspirin for you. Suffer from alcohol – related liver disease (noncirrhotic). Have high blood pressure (your doctor may want to monitor you more closely). Have allergic disease. Have diabetes. If you are elderly (your doctor may want to monitor you more closely). If you drink alcohol (wine, beer, spirits) when you are taking these tablets, it may make your stomach more sensitive to aspirin. If you are not sure whether any of the above apply to you, speak to a doctor or pharmacist before taking this medicine. Children and adolescents: Do not give this medicine to children under the age of 16 unless your doctor tells you. This is because there is a possible association between Aspirin and Reye’s Syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. Other medicines and Dispersible Aspirin 75 mg Tablets: Tell your doctor or pharmacist if you are already taking or have recently taken any of the following medicines, including medicines obtained without a prescription as their effectiveness may be influenced by aspirin if taken at the same time. Metoclopramide (for sickness and digestive disorders) Medication to lower blood sugar if you are diabetic e.g., metformin / glibenclamide or insulin. Blood thinning medicines such as heparin, warfarin or ticlopidine. Corticosteroids e.g. hydrocortisone (which can be used for arthritis, asthma and inflammatory conditions) Any pain relieving or anti-inflammatory medicines or steroids for pain and inflammation e.g. ibuprofen Medicines used to treat high blood pressure or congestive heart failure (e.g., captopril,enalapril or lisinopril) Diuretics to treat water retention e.g. spironolactone. Epilepsy medicines e.g. phenytoin, sodium valproate. Methotrexate (for psoriasis, rheumatoid arthritis, Crohn’s disease or tumours some types of cancer) Acetazolamide (a medicine for the eye disorder, glaucoma, epilepsy and water retention) Antacids for acid indigestion or absorbents e.g., kaolin for diarrhoea Gout medications eg probenecid or sulphinpyrazone Sulphonamide antibiotics e.g., co-trimoxazole Some anti-depressants known as SSRIs e.g. citalopram, fluoxetine, paroxetine. Mifepristone (for termination of pregnancy) – do not take this medicine for 8 – 12 days after taking mifepristone Zafirluklast (for asthma). Taking Dispersible Aspirin 75 mg Tablets with food and drink: Avoid taking alcohol while taking Dispersible Aspirin 75 mg Tablets. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or trying for a baby, unless directed by your doctor. Aspirin should not be taken in the last three months of pregnancy. Do not take this medicine if you are breast-feeding Patient Information Leaflet for Dispersible Aspirin 75 mg Tablets Read all of this leaflet carefully before you start this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. TEVA UK Ref: EAS695b 84390-X LEA ASPIRIN DISP 75mg TAB GENERIC (ASP) <EBN 05 September 2017 Version: 1 Colours Used: Dim’s Changed?: Length: Width: Depth: Foil Width: YES 323 mm 160 mm N/A N/A BLACK Template

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Top of page cut-off to middle of registration m

ark: 44 mm

.

Ph

arma co

de 2156

In this leaflet:1. What Dispersible Aspirin 75 mg Tablets

are and what they are used for?2. What you need to know before you take

Dispersible Aspirin 75 mg Tablets 3. How to take Dispersible Aspirin 75 mg

Tablets 4. Possible side effects 5. How to store Dispersible Aspirin 75 mg

Tablets 6. Contents of the pack and other

information

1. WHAT DISPERSIBLE ASPIRIN 75 MG TABLETS ARE AND WHAT THEY ARE USED FOR?

These tablets contain Aspirin (acetylsalicylicacid) which belongs to a group ofmedicines known as antiplatelet agents.Platelets are cells in the blood that causethe blood to clot. An antiplatelet agenthelps to prevent blood clotting. DispersibleAspirin 75mg Tablets is used to helpprevent further heart disease such as heartattacks (myocardial infarctions) or strokesin people who have previously sufferedthese conditions or who have under goneby-pass surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DISPERSIBLE ASPIRIN 75 MG TABLETS

Before starting long term use of Aspirinyou must consult your doctor who willdiscuss the benefits and risks of thistherapy with you.

Do not take these tablets if you:• Are allergic (hypersensitive) to Aspirin,

any other salicylates or any of the other ingredients of this medicine (listed in section 6).

• Have a stomach or duodenal ulcer or have had problems with ulcers in the past.

• Suffer from haemophilia or any other excessive bleeding condition.

• Suffer from gout. • Are taking blood thinning (anti-coagulant)

medication.• Have a history of hypersensitivity reactions

(eg asthma, rhinitis, urticaria) induced by pain relieving or anti-inflammatory medicines (eg NSAIDs or salicylates).

• Have severe liver or kidney problems.• Have asthma or have ever had it in the

past or suffer from tightness in the chest.• Are on a high dose of methotrexate

(15mg per week or more). If you are not sure, check with your doctor. Also see section ‘Using other medicines.’

• Are in the last 3 months of pregnancy or are breast feeding, unless advised by a doctor.

Warning and precautions:Take special care and tell your doctorbefore taking Dispersible Aspirin 75 mgtablets if you: • Are suffering from dehydration (feeling

constantly thirsty)• Have been told you are deficient in

glucose-6-phosphate dehydrogenase (G6PD), as you may experience anaemia.

• Are taking this product for the first time. Your doctor will be able to advise on the relative benefits and risks of long-term treatment with aspirin for you.

• Suffer from alcohol – related liver disease (noncirrhotic).

• Have high blood pressure (your doctor may want to monitor you more closely).

• Have allergic disease.• Have diabetes.• If you are elderly (your doctor may want

to monitor you more closely).If you drink alcohol (wine, beer, spirits)when you are taking these tablets, it maymake your stomach more sensitive to aspirin.

If you are not sure whether any of theabove apply to you, speak to a doctor orpharmacist before taking this medicine.

Children and adolescents:Do not give this medicine to children underthe age of 16 unless your doctor tells you.This is because there is a possibleassociation between Aspirin and Reye’sSyndrome when given to children. Reye’ssyndrome is a very rare disease, which canbe fatal.

Other medicines and Dispersible Aspirin75 mg Tablets:Tell your doctor or pharmacist if you arealready taking or have recently taken anyof the following medicines, includingmedicines obtained without a prescriptionas their effectiveness may be influencedby aspirin if taken at the same time.• Metoclopramide (for sickness and

digestive disorders) • Medication to lower blood sugar if you are

diabetic e.g., metformin / glibenclamide or insulin.

• Blood thinning medicines such as heparin,warfarin or ticlopidine.

• Corticosteroids e.g. hydrocortisone (which can be used for arthritis, asthma and inflammatory conditions)

• Any pain relieving or anti-inflammatory medicines or steroids for pain and inflammation e.g. ibuprofen

• Medicines used to treat high blood pressure or congestive heart failure (e.g.,captopril,enalapril or lisinopril)

• Diuretics to treat water retention e.g. spironolactone.

• Epilepsy medicines e.g. phenytoin, sodium valproate.

• Methotrexate (for psoriasis, rheumatoid arthritis, Crohn’s disease or tumours some types of cancer)

• Acetazolamide (a medicine for the eye disorder, glaucoma, epilepsy and water retention)

• Antacids for acid indigestion or absorbents e.g., kaolin for diarrhoea

• Gout medications eg probenecid or sulphinpyrazone

• Sulphonamide antibiotics e.g., co-trimoxazole

• Some anti-depressants known as SSRIs e.g. citalopram, fluoxetine, paroxetine.

• Mifepristone (for termination of pregnancy) – do not take this medicine for 8 – 12 days after taking mifepristone

• Zafirluklast (for asthma).

Taking Dispersible Aspirin 75 mg Tabletswith food and drink:Avoid taking alcohol while takingDispersible Aspirin 75 mg Tablets.

Pregnancy and breast-feedingAsk your doctor or pharmacist for advicebefore taking this medicine if you arepregnant or trying for a baby, unlessdirected by your doctor. Aspirin should notbe taken in the last three months ofpregnancy. Do not take this medicine if youare breast-feeding

Patient Information Leaflet for

Dispersible Aspirin 75 mg Tablets

Read all of this leaflet carefully before you start this medicine because it contains importantinformation for you. Always take this medicine exactly as described in this leaflet or as yourdoctor or pharmacist has told you. -Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice.- 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.

TEVA UK Ref: EAS695b 84390-X LEA ASPIRIN DISP 75mg TAB GENERIC (ASP) <EBN 05 September 2017Version: 1

Colours Used:Dim’s Changed?:Length:Width:Depth:Foil Width:

YES323 mm160 mm

N/AN/A

BLACK

Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

EAS695b84390-X

160 x 323

Dispersible Aspirin 75 mg Tablets containlactoseIf you have been told by your doctor thatyou have an intolerance to some sugars,contact your doctor before taking thismedicinal product.

3. HOW TO TAKE DISPERSIBLE ASPIRIN 75 MG TABLETS

Always take this medicine exactly as yourdoctor or pharmacist has told you. Check with your doctor or pharmacist ifyou are not sure.

Dosage in adults, the elderly and childrenover the age of 16 years:The usual dosage is 1 to 2 tabletsdissolved in water, once a day . In somepeople a higher dose of up to 4 tablets aday, as a starting dose, may be prescribed.Do not take this many tablets unless told toby your doctor. Always follow your doctor’sinstructions on how to take your medicine.

When taking this medicine, it is importantto remember the following: • Do not give to children aged under 16

years old unless told to by your doctor. • Do not exceed the stated dose. • If you take more Dispersible Aspirin 75 mg

Tablets than you should,Seek medical attention IMMEDIATELY if you accidentally take too many tablets. Take this leaflet and any packaging with you to show what you have taken.

• If you forget to take Dispersible Aspirin 75 mg Tablets,If you forget to take a dose, do not take a double dose to make up for the misseddose.

• If you stop taking Dispersible Aspirin 75 mg Tablets,Before you decided to stop taking this medicine, please speak to your doctor orpharmacist

If you have any further questions on theuse of this medicine, ask your doctor orpharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Dispersible Aspirin 75 mgTablets can cause side effects, although noteveryone gets them. If you get any of thefollowing side effects, stop taking thetablets immediately. See a doctor or go toyour nearest Accident and EmergencyDepartment at once:

Allergic reactions: The following reactions may mean you arehaving an allergic reaction to this medicine: • Asthma, worsening of asthma,

unexplained wheezing or shortness of breath.

• Swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing).

• Rapid heart rate, low blood pressure, collapse.

• Also, there may be skin reaction (including hives, rash and itching) – veryrarely these can be severe with blistering and peeling skin.

Stomach and bowel problems including: • Stomach discomfort or pain, nausea,

indigestion or heartburn, stomach ulcer. • Vomit with blood or dark particles (like

coffee grounds).• Black tarry stools or blood passed in

your stools. • Worsening of bowel problems (ulcerative

colitis or Crohn’s disease).

Blood disorders which can cause: • Unexplained or unusual bruising or

bleeding. • Sore throat or mouth ulcers. • Fever (high temperature). • Extreme paleness or weakness and

exhaustion. • Nose bleeds (if a nose bleed is severe or

lasts for a long time, talk to your doctor straight away).

• Unusual bleeding which may cause blood in the urine, coughing up blood or a stroke due to bleeding in the brain.

• Pain in your lower abdomen or back, difficulty in passing urine – this maybe asign of kidney stones.

Other side effects that may occur includethose listed below.

Other stomach and intestine effectsincluding:• Diarrhoea, flatulence (excess wind),

constipation and vomiting (being sick).

Nervous system problems including: • Hearing disorders (such as tinnitus, a

ringing in the ears), vertigo (a type of dizziness) and mental confusion.

Reporting of side effects:If you get any side effects, talk to yourdoctor or pharmacist. This includes anypossible side effects not listed in thisleaflet. You can also report side effectsdirectly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard. By reportingside effects you can help provide moreinformation on the safety of this medicine.

5. HOW TO STORE DISPERSIBLE ASPIRIN 75 MG TABLETS

Keep your your medicine out of the sightand reach of children.Do not store above 25˚C. Store in the original packaging to protectfrom light and moisture. Do not use this medicine after the expirydate printed on the packaging. The expirydate refers to the last date of that month.Do not use this medicine if you notice atablet is powdery or discoloured.Do not throw away any medicines viawastewater or household waste . Ask yourpharmacist how to throw away medicinesyou no longer use. These measures willhelp protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dispersible Aspirin 75 mg Tabletscontains The active ingredient in these tablets isaspirin (acetylsalicylic acid) 75 mg.The other excipients are starch, lactose,sodium saccharin, citric acid, sodium laurylsulphate, calcium carbonate and talc.

What Dispersible Aspirin 75 mg Tabletslooks like and contents of the packThese tablets are small white round tabletswith aD over 75 on one face and plain onthe other.

Dispersible Aspirin 75 mg Tablets areavailable in blister packs of 24, 28, 56 or100 tablets and they are also available incontainer packs of 25, 28, 32, 50, 56, 60,100 or 1000 tablets

Not all pack sizes are marketed.

The marketing authorisation holder andmanufacturer isAspar Pharmaceuticals Ltd,29 - 30 Capitol Way, Colindale, London,NW9 0EQ.

ManufacturerAspar Pharmaceuticals Ltd. Acrewood Way, St Albans, AL4 0JY, United Kingdom.

PL 08977/0007

This leaflet was last revised in August2017.

TEVA UK Ref: EAS695b 84390-X LEA ASPIRIN DISP 75mg TAB GENERIC (ASP) <EBN 05 September 2017Version: 1

Colours Used:Dim’s Changed?:Length:Width:Depth:Foil Width:

YES323 mm160 mm

N/AN/A

BLACK

Template

Teva UK Ltd. Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG.