Patient Self- reporting Questionnaire of Adverse Drug Reactions

InstructionPlease answer all the questions in parts 1 and 2 by tickingor filling in where appropriate

Name of your Lipid-lowering medicineGeneric name Simvastatin

(Please read from the label of your package)Trade name Zimmex®

1. Gender1 Male2Female

2. Age…...... Years

3. Education

1 Primary school5 Bachelor degree

2 Secondary school6 Master degree

3 High school7 Doctoral degree

4 Diploma8  Others(Please indicate)......

4. When was the last time that you had visited Srinagarind hospital?Month...... Year ......

5. How many times a day are/were you takingZimmex®?

Once a dayTwice a day

6. How many tablets or capsules are/were you taking each time?

1 Tablet/Capsule2 Tablets/CapsulesOther (please indicate)......

7. When did you start taking Zimmex®? Month...... Year ......

8. What condition did your doctor prescribe this medicine for?

......

9. Since you started takingZimmex®, have you been in hospital for any reason?

1 No

2 Yes, and the reason was/were ......

10. Do you have any other medical conditions?

1 Yes, (please list them)......

2 No

11. Do you regularly take other medicines during the last 12 months?

1 No

2 Yes (Please list them) ......

......

The purpose of this questionnaire is to find out whether you have experienced any side effects while taking Simvastatin or Zimmex®. Please be assured this does not mean your medicine can cause all ofthe side effects listed here. If you are no longer taking your medicine, we would still like you tocomplete the questionnaire.

During the last 12 months , have you had any of the following symptoms which you thinkmay be side effects caused bySimvastatin or Zimmex®? Please tick all the boxes which you think apply.Only indicate the problems which were not present before you started takingSimvastatin or Zimmex®.

12. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your skin?

1 None2 Bleeding

3 bruising4 burning sensation

5 flushing of skin/ hot flush 6increased sensitivity of skin to light

7 itching of skin8 pale skin

9puffy skin 10 pins and needles sensation

11 skin rash 12 yellowing of skin

13 Other (please indicate)......

13. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your hair or nails?

1 None4 hair loss

2 change in fingernails5 excessive hair

3 Other (please indicate)......

14. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your muscles, bones or joints?

1 None5 trembling & shaking of fingers & nails

2 Swag6 muscle pain (please indicate back arms legs)

3 muscle weakness7 unsteadiness on feet

4 bone or joint pain8 unusual or uncontrolled body movement

9 Other (please indicate)......

15. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your head?

1 None3 migraine headache

2 headache4 Other (please indicate)......

16. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your vision?

1 None3 double vision

2 blurred vision4 Other (please indicate)......

17.Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your eyes?

1 None4 yellowing of white eyes

2  itchy or irritated or inflamed eyes or eyelids5 unusual movement of the eyes

3  inability to move eyes6 Other (please indicate)......

18. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your hearing or ears?

1 None3 feeling fullness in the ears

2 change or difficulty in hearing4 ringing, buzzing or noises in ears

5 Other (please indicate)......

19. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your mouth or gums ?

1 None3dry mouth or throat

2  bleeding from gums4Other (please indicate)......

20. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your nose, throat, neck or voice?

1 None4 runny or stuffy nose

2 difficulty talking5 sore throat

3 slurred speech6 Other (please indicate)......

21. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your breathing or lungs?

1 None4 fast breathing

2 cough5 slow breathing

3 difficulty breathing6 Other (please indicate)......

22. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your heart or circulation?

1 None3 missed heart beat

2 palpitations/ racing heart4 increased blood pressure

5 Other (please indicate)......

23.Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your stomach or digestive system?

1 None6 increased in appetite

2  bloated feeling or gas7 pain or cramps in lower abdomen

3 decreased in appetite8 nausea or vomiting

4  indigestion9 vomiting blood or material that looks like coffee grounds

5 heartburn10Other (please indicate)......

24. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your rectum or bowel movements?

1 None4 bloody stool

2 diarrhoea5 constipation

3  black tarry stool6 Other (please indicate)......

25. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your kidneys, bladder or urinary system?

1 None5 passing water less often

2  burning, discomfort or pain while passing water6 passing water more often

3  dark brown urine7 bloody urine

4 difficulty in passing water8 cannot passing water

9 Other (please indicate)......

26. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your sexual function (ability)?

1 None4 decreased in sexual ability

2  decreased in sexual desire5 increased in sexual desire

3  Does not apply6 Other (please indicate)......

27. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your reproductive (sex) organ?

1 None3 burning or irritated penis

2 abnormal or change in vaginal bleeding4 Other (please indicate)......

28. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your nervous system?

1 None4 confusion or delirium

2  light-headed when getting up from5 dizziness or staggering (vertigo)

a lying or sitting position or feeling faint6 Other (please indicate)......

3 increased in convulsions (seizures)

29. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine related to your mental health?

1 None7 anger or aggression

2  anxiety(nervousness) or agitation8  change in mood

3 loss of memory9 hallucinations(seeing, hearing or feeling things that are not there)

4 difficulty concentrating or learning10 though of suicide

5 reduction in sleep11 nightmares

6 increased sleep or drowsiness12 Other (please indicate)......

30. Have you had any of the following symptoms which you think may be due to side effectsfrom this medicine?

1 None6increased sweating

2 increased sensitivity to cold7decreased sweating

3 fever8unusual tiredness or weakness

4  flu-like symptoms9weight gain

5 weight loss 10 excessive thirst

11Other (please indicate)......

31. Which, if any, of the symptoms in question 12-30 have bothered you most ?

1 None(please skip to question 33)

2 ......

32. How much has this symptom(s) in question 31 bothered you at its worst ?

1  minimally4 severely

2 mildly5 very severely

3 moderately6 does not apply

33. Have you told your doctor about any of these symptom(s)?

1 none4 all

2  some5 does not apply

3 I'm not sure

34. When did you stop this medicine?Month...... Year......

35. Why did you stop?

1 I felt I didn’t need it any longer

2 The doctor said I didn’t need it any longer

3 The doctor told me to stop because I was having problems with it

4 I decided to stop because I was having problems with it

5 I felt it wasn’t helping me

6 Other (please explain)......

36. Have any of the symptoms you have described gone away?

1  Yes2 No3 Does not apply

If yes, please say which one......

37. Have any other symptoms started after stopping______?

1  Yes 2 No

If yes, please say which one......

Thank you for your time and co-operation

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