Consumer medicine information

Dolapril 0.5 mg Capsules

Trandolapril

BRAND INFORMATION

Brand name

Dolapril

Active ingredient

Trandolapril

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Dolapril 0.5 mg Capsules.

1. Why am I using DOLAPRIL?


DOLAPRIL contains the active ingredient trandolapril. DOLAPRIL is used to treat high blood pressure (hypertension) and also to treat some heart conditions.
For more information, see Section 1. Why am I using DOLAPRIL? in the full CMI.

2. What should I know before I use DOLAPRIL?


Do not use if you have ever had an allergic reaction to trandolapril 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 DOLAPRIL? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with DOLAPRIL 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 DOLAPRIL?

  • The usual dosage is one or two capsules taken once daily, up to a maximum of 4mg (two 2mg capsules) once daily.

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

5. What should I know while using DOLAPRIL?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using trandolapril.
  • Have your blood pressure checked when your doctor says, to make sure DOLAPRIL is working.
  • If you become pregnant while taking DOLAPRIL tell your doctor immediately.
  • If you feel light-headed or dizzy after taking your first dose of DOLAPRIL, or when your dose isincreased, tell your doctor immediately.
  • Tell your doctor if you have excessive vomiting and/or diarrhoea while taking DOLAPRIL.
Things you should not do
  • Do not give DOLAPRIL to anyone else, even if they have the same condition as you.
  • Do not take DOLAPRIL to treat any other complaints unless your doctor tells you to.
  • Do not stop taking DOLAPRIL, or lower the dosage, without checking with your doctor.
Driving or using machines
  • DOLAPRIL may cause dizziness, light-headedness or tiredness in some people. Make sureyou know how you react to DOLAPRIL before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.
Drinking alcohol
  • If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
  • Keep your capsules in a cool dry place where the temperature stays below 25°C.

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

6. Are there any side effects?


Tell your doctor if the following worry you: dizziness, nausea, vomiting, diarrhoea, indigestion, persistent dry cough, headache, unusual tiredness, aching, tender or weak muscles and taste disturbance.
Tell your doctor immediately if you notice any palpitations, signs of infection or skin problems.
Stop taking DOLAPRIL and tell your doctor immediately or go to your nearest hospital if the following happen; fainting, swelling of face, lips, mouth, tongue or throat, severe dizziness, chest pain, rapid, shallow breathing, cold clammy skin or a rapid, weak pulse. 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

Dolapril

Active ingredient

Trandolapril

Schedule

S4

 

1 Name of Medicine

Trandolapril.

2 Qualitative and Quantitative Composition

Dolapril 0.5 capsules contain 0.5 mg of trandolapril.
Dolapril 1 capsules contain 1 mg of trandolapril.
Dolapril 2 capsules contain 2 mg of trandolapril.
Dolapril 4 capsules contain 4 mg of trandolapril.
Excipients with known effect. The capsules contain sugars as lactose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dolapril 0.5 capsules. White opaque capsule with 'TN' over '5' on the cap.
Dolapril 1 capsules. Peach and scarlet opaque capsule with 'TN' over '1' on the cap.
Dolapril 2 capsules. Scarlet opaque capsule with 'TN' over '2' on the cap.
Dolapril 4 capsules. White opaque capsule with 'TN' over '4' on the cap.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).
In clinical trials, trandolapril doses of up to 16 mg have been administered and were well tolerated. There is no experience with overdosage. Symptoms expected with ACE inhibitors are severe hypotension, shock, stupor, bradycardia, electrolyte disturbance and renal failure. In the event of overdosage following recent ingestion, consideration should be given to emptying the stomach contents. Blood pressure should be monitored and, if hypotension develops, volume expansion should be considered. There is no specific antidote for trandolapril overdose.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Trandolapril had no mutagenic or clastogenic activity in a standard battery of tests.
Carcinogenicity. At least one ACE inhibitor has caused an increase in the incidence of oxyphilic renal tubular cells and oncocytomas in rats. The potential of ACE inhibitors to cause this effect in humans is unknown. Moreover, the progression of oxyphilic cells to oncocytomas is rare in humans and, when it does occur, it is considered to be benign. No carcinogenic effect has been noted with long-term rat (24 months up to 8 mg/kg/day) or mice (18 months up to 25 mg/kg/day) studies with trandolapril.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Trandolapril is a colourless, crystalline powder that is soluble in chloroform, dichloromethane and methanol, slightly soluble in water and sparingly soluble in hydrochloric acid.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTRANDO.gif CAS number. CAS no.: 87679-37-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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