Consumer medicine information

Simipex 1 mg Tablets

Pramipexole dihydrochloride monohydrate

BRAND INFORMATION

Brand name

Simipex

Active ingredient

Pramipexole dihydrochloride monohydrate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Simipex 1 mg Tablets.

1. Why am I using SIMIPEX?


SIMIPEX contains the active ingredient Pramipexole dihydrochloride monohydrate.
SIMIPEX is used used in the treatment of Parkinson's disease and Restless Legs Syndrome (RLS).
For more information, see Section 1. Why am I using SIMIPEX? in the full CMI.

2. What should I know before I use SIMIPEX?


Do not use if you have ever had an allergic reaction to SIMIPEX (pramipexole), 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 SIMIPEX? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with SIMIPEX and affect how it works. Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
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 SIMIPEX?

  • For Parkinson's disease, SIMIPEX 0.125mg tablet should be taken in three times per day. Your daily dose will be increase every week by your doctor until a suitable daily dose is reached.
  • For Restless Legs Syndrome, the usual starting dose is one SIMIPEX 0.125mg tablet once a day, 2 to 3 hours before you go to bed. Your doctor may increase your dose every 4 to 7 days if needed.
  • SIMIPEX tablets should be swallowed whole with a glass of water. SIMIPEX can be taken with or without food.
  • More instructions can be found in Section 4. How do I use SIMIPEX? in the full CMI.

5. What should I know while using SIMIPEX?

Things you should do
  • Tell your doctor if you become pregnant while taking SIMIPEX. Special care is recommended during pregnancy. The benefits of SIMIPEX must be assessed against the possible effects on your unborn child.
Things you should not do
  • Do not take SIMIPEX to treat any other complaint unless your doctor says so.
  • Do not give this medicine to anyone else, even if their symptoms are similar to yours.
Driving or using machines
  • SIMIPEX may cause drowsiness, hallucinations and episodes of sudden onset of sleep, in some people. If affected, do not drive or operate machinery.
Looking after your medicine
  • Keep SIMIPEX Tablets in a cool dry and dark place where the temperature is below 30°C. Keep tablets in the packet until used, to protect from light.

For more information, see Section 5. What should I know while using SIMIPEX? 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 serious side effects are: loss of memory, fainting, signs of allergy such as rash or hives on the skin, swelling of the face, lips, tongue or other parts of the body, wheezing or difficulty breathing, excessive sleepiness or sudden onset of sleep during normal daily activities, compulsive behaviour such as gambling, hypersexuality, shopping, eating, medication use and repetitive purposeless activities, mental illness causing severe suspiciousness (paranoia), shortness of breath or tightness in the chest. shortness of breath, swelling of the feet or legs due to fluid build-up (heart failure)

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

Simipex

Active ingredient

Pramipexole dihydrochloride monohydrate

Schedule

S4

 

1 Name of Medicine

Pramipexole dihydrochloride monohydrate.

2 Qualitative and Quantitative Composition

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Simipex tablets are round and white for each strength.
Simipex 0.125 mg tablets are round, while tablets marked on one side with the letter "A" and plain on the other side..
Simipex 0.25 mg tablets are round, white tablets marked on one side with the letter "B" and scored on the other side.
Simipex 1 mg tablets are round, white tablets marked on one side with the letter "D" and scored on the other side.
Simipex tablets 0.5 (round, white tablets marked on one side with the letter "C" and scored on the other side) and 1.5 mg tablets (round, white tablets marked on one side with the letter "E" and scored on the other side) are not currently marketed in Australia.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact Poisons Information Centre on 13 11 26 (Australia).
Symptoms. There is no clinical experience with massive overdosage. The expected adverse events should be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Treatment. There is no established antidote for overdosage of a dopamine agonist. If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated. Management of the overdose may require general supportive measures, intravenous fluids and electrocardiogram monitoring.
Haemodialysis has not been shown to be helpful.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Pramipexole was not mutagenic in in vitro assays for gene mutation, or cause chromosomal damage in in vitro and in vivo tests for clastogenic activity. Pramipexole was negative in an in vitro test for cell transformation.
Carcinogenicity. Two-year carcinogenicity studies with pramipexole have been conducted in mice and rats. Pramipexole was administered in the diet to mice at doses of 0.3, 2 and 10 mg/kg/day (the plasma levels were at least 0.2, 1.2, and 5.7 times the observed Cmax in humans dosed 1.5 mg three times daily (tid)). Pramipexole was administered in the diet to rats at 0.3, 2 and 8 mg/kg/day (0.8, 5 and 20 times the highest clinical dose on a mg/m2 basis).
Increased incidences of testicular Leydig cell adenomas were found in all groups of treated male rats. In contrast to the findings in rats, examination of the testes from mice after two years of treatment did not exhibit evidence of a drug related increase in Leydig cell adenomas. These findings are of questionable significance in humans because of their high background incidence in rats, the absence of similar changes in mice treated with pramipexole for two years, and the probable involvement of endocrine mechanisms that are not relevant to humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Pramipexole dihydrochloride monohydrate is a white to off white crystalline powder. Freely soluble in water, soluble in methanol, sparingly soluble to slightly soluble in ethanol (96%) and practically insoluble in methylene chloride.
The chemical name of pramipexole is (S)-2-amino-4,5,6,7-tetrahydro-6-propylamino-benzothiazole, [C10H17N3S], CAS registry number 104632-26-0, molecular weight 211.33.
Pramipexole tablets contain C10H17N3S.2HCl.H2O molecular weight 302.3, CAS registry number 191217-81-9 for which the Australian Approved Name is pramipexole dihydrochloride monohydrate.
The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPRDMON.gif CAS number. CAS: 191217-81-9 (pramipexole dihydrochloride monohydrate).

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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