Consumer medicine information

1. Why am I using Tadalafil GH?

Tadalafil GH contains the active ingredient tadalafil. Tadalafil GH is used to treat erectile dysfunction and urinary symptoms associated with benign prostatic hyperplasia in adult men.
For more information, see Section 1. Why am I using Tadalafil GH? in the full CMI.

2. What should I know before I use Tadalafil GH?

Do not use if you have ever had an allergic reaction to tadalafil or any of the ingredients listed at the end of the CMI. Do not take Tadalafil GH if you are currently taking any nitrates or amyl nitrite.
Talk to your doctor or pharmacist if you have any other medical conditions such as heart problems or take any other medicines.
For more information, see Section 2. What should I know before I use Tadalafil GH? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Tadalafil GH 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 Tadalafil GH?

• Always take Tadalafil GH exactly as your doctor has told you.

• Follow all directions given to you by your doctor or pharmacist.

5. What should I know while using Tadalafil GH?

6. Are there any side effects?

Tadalafil GH may cause: chest pain; headache or migraine; flushing; sweating; nausea or vomiting; fatigue; back pain; muscle pain. Serious side effects may include: chest pain; increased heart beat; prolonged and painful erection; erection that lasts longer than 4 hours; partial, temporary or permanent vision changes in one or both eyes; sudden decrease or loss of hearing and seizures.
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.

1 Name of Medicine

Tadalafil.

2 Qualitative and Quantitative Composition

The active ingredient in Tadalafil GH tablets is tadalafil. Three strengths are available, containing 5 mg, 10 mg and 20 mg of tadalafil.
List of excipients with known effects. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tadalafil GH 5 mg tablets are yellow coloured, round shaped, biconvex film-coated tablets debossed with 'T5' on one side and plain on other side.
Tadalafil GH 10 mg tablets are yellow coloured, round shaped, biconvex film-coated tablets debossed with 'T10' on one side and plain on other side.
Tadalafil GH 20 mg tablets are yellow coloured, round shaped, biconvex film-coated tablets debossed with 'T20' on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

Single doses of up to 500 mg of tadalafil have been given to healthy subjects and multiple daily doses of up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Haemodialysis contributes negligibly to tadalafil elimination.
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. Tadalafil was not mutagenic or genotoxic in in vitro bacterial and mammalian cell assays, and in in vitro human lymphocytes and in vivo rat micronucleus assays.
Carcinogenicity. Oral administration of tadalafil at doses of 400 mg/kg/day for up to two years in mice resulted in increased development of hepatocellular adenomas in males but not in females. Tadalafil also caused hepatocellular microsomal enzyme induction in rodents and it is possible that this could lead to an increased incidence of hepatocellular neoplasms. However, hepatic microsomal enzyme induction is a common non-genotoxic biologic effect associated with hepatocellular tumour formation in rodents and is not considered relevant to human cancer risk. The no-effect dose of 60 mg/kg/day was associated with systemic exposure to tadalafil approximately 5-7-fold that expected in men taking the maximum recommended dose of 20 mg daily, based on unbound drug concentrations.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Tadalafil is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTADFIL.gif Chemical name: (6R,12aR)-6-(1,3- benzodioxol-5-yl)-2- methyl-2,3,6,7,12, 12a-hexahydropyrazino [1',2':1,6]-pyrido [3,4-b]indole-1,4- dione.
Molecular formula: C₂₂H₁₉N₃O₄.
Molecular weight: 389.4.
CAS number. 171596-29-5.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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