Consumer medicine information

Fibsol 5 mg Tablets

Lisinopril

BRAND INFORMATION

Brand name

Fibsol

Active ingredient

Lisinopril

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fibsol 5 mg Tablets.

1. Why am I using FIBSOL?


FIBSOL contains the active ingredient lisinopril (as dihydrate). FIBSOL is used to lower high blood pressure, which doctors call hypertension. It is also used to treat heart failure and patients who have just had a heart attack. For more information, see Section 1. Why am I using FIBSOL? in the full CMI.

2. What should I know before I use FIBSOL?


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

3. What if I am taking other medicines?


Some medicines may interfere with FIBSOL 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 FIBSOL?

  • Take FIBSOL as prescribed by your doctor. This depends on your condition and whether you are taking other medicines.

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

5. What should I know while using FIBSOL?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using FIBSOL.
  • Have your blood pressure checked when your doctor says to make sure FIBSOL is working.
  • Call your doctor straight away if you: feel any light-headedness or dizziness, become pregnant, have excessive vomiting and/or diarrhoea while taking FIBSOL.
  • Make sure you drink enough water during exercise and hot weather when you are taking FIBSOL.
  • Go to your doctor regularly for a check-up.
Things you should not do
  • Do not take FIBSOL to treat any other complaints unless your doctor tells you to.
  • Do not give FIBSOL to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how FIBSOL affects you.
Drinking alcohol
  • Your doctor may advise you to limit your alcohol intake.
Looking after your medicine
  • Store below 25°C.
  • Store in a cool, dry place, away from young children.

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

6. Are there any side effects?


There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details). The most common and serious side effects are passing less urine, chest pain, angina, swelling of the face, lips, mouth, tongue or throat, wheeziness, difficulty breathing, collapse, numbness/weakness of arms or legs, pinkish, hives, fainting, heart beats changes, skin problems, infections, bruising easily, severe abdominal pain, yellowing of the skin and/or eyes, dehydration and hallucinations. 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

Fibsol

Active ingredient

Lisinopril

Schedule

S4

 

1 Name of Medicine

Lisinopril dihydrate.

2 Qualitative and Quantitative Composition

Lisinopril dihydrate is a white to off white crystalline powder that is soluble in water, sparingly soluble in methanol and practically insoluble in ethanol.
Fibsol tablets come in three strengths and contain lisinopril dihydrate equivalent to 5 mg, 10 mg or 20 mg of lisinopril.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Fibsol 5. Off white round tablet, debossed with "L" break-line "5" on one side and plain on other side.
Fibsol 10. Off white round tablet, debossed with "L" break-line "10" on one side and plain on other side.
Fibsol 20. Off white round tablet, debossed with "L" break-line "20" on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).
There are no data on overdosage in humans. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril may be removed from the general circulation by haemodialysis.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Lisinopril was not genotoxic in assays for gene mutations, chromosomal damage and DNA damage.
Carcinogenicity. There was no evidence of a tumorigenic effect when lisinopril was administered for 105 weeks to male and female rats at doses up to 90 mg/kg/day or when lisinopril was administered for 92 weeks to male and female mice at doses up to 135 mg/kg/day. At least one other ACE inhibitor has caused an increase in the incidence of oxyphilic renal tubular cells and oncocytomas in rats. The potential for lisinopril to cause a similar effect is unknown.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Lisinopril dihydrate. The chemical name for lisinopril dihydrate is N-[N-[(1S)-1-carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLISDIH.gif Molecular formula: C21H31N3O5.2H2O. Molecular weight: 441.53.
CAS number. CAS No.: 83915-83-7.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

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