Consumer medicine information

Lariam 250 mg Tablets

Mefloquine

BRAND INFORMATION

Brand name

Lariam

Active ingredient

Mefloquine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Lariam 250 mg Tablets.

1. Why am I using Lariam®?


Lariam® contains the active ingredient mefloquine. Lariam® is used to is used to prevent and treat malaria.
For more information, see Section 1. Why am I using Lariam®? in the full CMI.

2. What should I know before I use Lariam®?


Do not use if you have ever had an allergic reaction to mefloquine 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 Lariam®? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Lariam® 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 Lariam®?

  • Your doctor will tell you how many Lariam® tablets to take and how often to take them.
  • For treatment of malaria, the first dose of Lariam® is 3 tablets. This is followed by a second dose of 2 tablets, 6 - 8 hours later. The total dose of Lariam® is usually 5 tablets.
  • For prevention of malaria, the dose is 1 tablet of Lariam® once weekly, always on the same day. The first tablet should be taken one week before you arrive in the malarial area. Subsequently, take 1 tablet for each week that you remain in the malarial area and 1 tablet per week for two weeks after you have left the malarial area.

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

5. What should I know while using Lariam®?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Lariam®.
  • Tell your doctor if you feel Lariam® is not helping your condition or if for any reason you have not taken Lariam® exactly as prescribed.
  • Tell your doctor immediately if you become pregnant while taking Lariam®.
Things you should not do
  • Do not stop using this medicine suddenly or change the dose without consulting your doctor.
  • Do not use Lariam® to treat other complaints unless instructed by your doctor or share Lariam® with anyone else.
Driving or using machines
  • Lariam® may cause dizziness, drowsiness or loss of balance in some people. These effects may occur for some time after stopping Lariam® treatment.
  • Make sure you know how you react to Lariam® before doing anything that could be dangerous.
Drinking alcohol
  • Alcohol can worsen the dizziness, drowsiness or loss of balance caused by Lariam®.
Looking after your medicine
  • Keep your tablets in the blister pack until it is time to take them.
  • Keep Lariam® in a cool dry place where the temperature stays below 30°C and out of reach of children.

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

6. Are there any side effects?


The side effects of Lariam® can be similar to symptoms of Malaria and last months after you stop taking Lariam®. Lariam® can in rare cases cause serious side effects including mood related disorders or mental problems.
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

Lariam

Active ingredient

Mefloquine

Schedule

S4

 

1 Name of Medicine

Mefloquine hydrochloride.

2 Qualitative and Quantitative Composition

Lariam tablets contain 250 mg mefloquine in the form of mefloquine hydrochloride (274.09 mg). Lariam (mefloquine) is an antimalarial belonging to the quinoline methanol group of medicines and is structurally related to quinine.
Excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets.
Lariam tablets are cylindrical biplanar, white to off-white, cross-scored with break bars on both faces and marked with "LA", "RI", "AM" and "CP" in each quadrant of one face.

4 Clinical Particulars

4.9 Overdose

Symptoms. In cases of overdosage with Lariam, the symptoms mentioned under Section 4.8 Adverse Effects (Undesirable Effects) may be more pronounced.
Treatment. Patients should be managed by symptomatic and supportive care following Lariam overdose. There are no specific antidotes. Monitor cardiac function (if possible by ECG) and neuropsychiatric status for at least 24 hours. Provide symptomatic and intensive supportive treatment as required, particularly for cardiovascular disturbances.
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. The genotoxic potential of mefloquine was assessed in bacterial, yeast and mammalian mutagenicity tests, in a host mediated assay in mice and a mouse micronucleus assay at appropriate concentrations or doses. In vitro tests were performed with and without metabolic activation. All assays returned negative results for mefloquine.
Carcinogenicity. The carcinogenic potential of mefloquine was investigated in 2 year feeding studies in mice and rats at doses up to 30 mg/kg/day, equivalent to 4 and 8 times the prophylactic dose on a mg/m2 basis. There were no treatment related increases in tumour incidence in either species.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: dl-erythro-alpha-2-piperidyl-2,8-bis(trifluoromethyl)-4-quinoline methanol. MW: 414.78.
Mefloquine is an odourless, bitter tasting, white crystalline powder. It is soluble in methanol and ethanol but practically insoluble in water. A 1% aqueous suspension has a pH of 5.6.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMEFHYD.gif CAS number. 51773-92-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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