Consumer medicine information

Ticalor 90 mg Tablets

Ticagrelor

BRAND INFORMATION

Brand name

Ticalor

Active ingredient

Ticagrelor

Schedule

S4

1. Why am I using TICALOR?


TICALOR contains the active ingredient ticagrelor. TICALOR is given if you have had a heart attack or unstable angina (angina or chest pain that is not well controlled).
For more information, see Section 1. Why am I using TICALOR? in the full CMI.

2. What should I know before I use TICALOR?


Do not use if you have ever had an allergic reaction to ticagrelor or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use TICALOR? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with TICALOR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use TICALOR?

  • The starting dose is two tablets at the same time. This dose will usually be given in the hospital. After that, the usual dose is one tablet twice daily.
  • Take your doses at around the same time every day. For example, one in the morning and one in the evening. It does not matter whether you take TICALOR with food or on an empty stomach.

More instructions can be found in Section 4. How do I use TICALOR? in the full CMI.

5. What should I know while using TICALOR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using TICALOR.
  • Take TICALOR exactly as your doctor has told you to.
  • Tell your doctor if you become pregnant while you are taking TICALOR.
  • Tell your doctor if you decide to breast feed your baby.
Things you should not do
  • Do not stop taking this medicine suddenly without talking to your doctor.
  • Do not give this medicine to anyone else, even if they have symptoms that seem similar to yours.
Driving or using machines
  • Be careful while driving or operating machinery.
Looking after your medicine
  • Keep your tablets in the blister pack until it is time to take them.
  • Keep it in a cool, dry place where the temperature stays below 25°C.
  • Do not store it or any medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car on hot days.

For more information, see Section 5. What should I know while using TICALOR? in the full CMI.

6. Are there any side effects?


All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Ticalor

Active ingredient

Ticagrelor

Schedule

S4

1 Name of Medicine

Ticagrelor.

2 Qualitative and Quantitative Composition

Each film-coated tablet contains 90 mg of ticagrelor.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Yellow coloured, round, biconvex, film coated tablets debossed with "90 and M" on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

Ticagrelor is well tolerated in single doses up to 900 mg. GI toxicity was dose-limiting in a single ascending dose study. Other clinically meaningful adverse effects which may occur with overdose include dyspnoea and ventricular pauses.
In the event of overdose, observe for these potential adverse effects and consider ECG monitoring.
There is currently no known antidote to reverse the effects of ticagrelor, and ticagrelor is not dialysable (see Section 5.2 Pharmacokinetic Properties, Special populations, Patients with renal impairment). Treatment of overdose should follow local standard medical practice. The expected effect of excessive ticagrelor dosing is prolonged duration of bleeding risk associated with platelet inhibition. If bleeding occurs appropriate supportive measures should be taken.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ticagrelor showed no genotoxic potential in assays for gene mutations (bacterial reverse mutation, mouse lymphoma TK) and chromosomal damage (rat micronucleus in vivo).
Carcinogenicity. No compound-related tumours were observed in a 2-year mouse study at oral doses up to 250 mg/kg/day (ca.18-fold the maximum human therapeutic exposure to ticagrelor). There was no increase in tumours in male rats at oral doses up to 120 mg/kg/day (ca. 15-fold the maximum human therapeutic exposure). Increases in uterine adenocarcinomas and hepatocellular adenomas/adenocarcinomas and decreases in pituitary adenomas and mammary fibroadenomas were observed in female rats at more than 25 times the maximum human therapeutic exposure to ticagrelor, with no change in tumour incidence seen at around 8 times the maximum human therapeutic exposure. The uterine tumours seen only in rats were hypothesised to result from a hormonal imbalance present in rats given high doses of ticagrelor. The benign liver tumours are considered secondary to the response by the liver to the metabolic load placed on the liver from the high doses of ticagrelor.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structure of ticagrelor is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTICAGR.gif CAS number. The CAS number for ticagrelor is 274693-27-5.
Molecular weight: 522.57.
Chemical name (IUPAC): (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-
difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]- 5-(2-hydroxyethoxy)cyclopentane-1,2-diol.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TICALOST.gif