250 mg mefloquine tablets
What Lariam is and what it is used for
Lariam kills various forms of malaria parasites and also affects some of the parasites that are insensitive to other malaria medicines.
Lariam is used to prevent and treat malaria. Malaria is caused by parasites that are transmitted to humans through a tropical mosquito. The parasites develop in human blood and destroy the red blood cells.
To minimize the risk of getting the disease and to protect yourself from possible serious side effects, you must read this leaflet carefully. Ask your doctor to explain if there is something you do not understand.
What you need to know before taking Lariam
Do not take Lariam if you have or have had:
- depression, suicidal ideation or self-harming behavior
- any other mental problem including anxiety, schizophrenia or lost contact with reality ( psychosis )
- seizures ( epilepsy or convulsions)
- allergy to mefloquine or substances related to mefloquine (eg chloroquine, quinidine and quinine) or any of the other ingredients of this medicine (listed in section 6).
- severe liver problems
- blackwater fever (a complication of malaria that affects the blood and kidneys).
If any of the above apply to you, talk to your doctor so that your doctor can prescribe another medicine for the prevention or treatment of malaria.
Also, talk to your doctor immediately if you are already being treated with halofantrine or if you have been prescribed halofantrine. Concomitant use of halofantrine (used to treat malaria ) and Lariam may cause severely slowed heart rate. Therefore, to avoid affecting your heart rate, do not take halofantrine if you are already taking or have taken Lariam in the last 15 weeks.
Take special care with Lariam:
Lariam can cause serious mental conditions in some patients. Talk to your doctor immediately if you get any of the following while using Lariam:
- suicidal thoughts
- self-harming behavior
- severe anxiety
- feelings of distrust of others ( paranoia )
- see or hear things that do not exist (hallucinations)
- nightmares / abnormal dreams
- insomnia
- Depression
- restlessness
- deviant behavior
- confusion.
Please seek medical attention immediately if you experience severe mental health problems or if the above is noted while taking Lariam. Lariam treatment should then be stopped immediately and replaced with another medicine to prevent malaria.
Also, make sure your doctor knows if you have:
- seizures ( epilepsy or convulsions)
- heart problems, especially changes in heart rhythm
- liver or kidney problems
- an intolerance to certain sugars such as lactose and galactose. In that case, you should not take Lariam.
- eye problems
- blood disease or disease of the lymphatic system (abnormal blood counts showing decreased or increased number of white blood cells , decreased number of red blood cells or platelets )
- neuropathy with symptoms such as numbness and tingling, weakness, added or aggravated instability in the feet or balance disorders or shaking of hands and fingers
- pneumonia , also called pneumonitis . This is a serious, potentially life-threatening allergic reaction in the lungs that can cause fever or chills, cough and breathing problems.
- had a mild to severe potentially life-threatening allergic reaction to Lariam or any of the other ingredients.
- regular or persistent low blood sugar due to a condition called congenital hyperinsulinism
Some side effects may occur after you stop taking Lariam. In a small number of patients, it has been reported that depression, dizziness or vertigo, and balance disorders may persist for months or longer after stopping treatment with Lariam.
Other medicines and Lariam:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (including medicines obtained without a prescription) before taking Lariam.
You must consult your doctor if you are taking:
- halofantrine, or if you have been prescribed halofantrine. See also section “ Do not take Lariam if you have or have had: ” above
- drugs such as quinine, quinidine , chloroquine used to treat or prevent malaria
- drugs for heart problems, or high blood pressure such as beta-receptor blockers and calcium channel blockers
- antihistamine is against allergies
- drugs for mental problems such as tricyclic antidepressants and phenothiazones
- drugs used to treat epilepsy such as valproate , carbamazepine, phenobarbital, phenytoin
- ketoconazole (used to treat fungal infections) – you should ask your doctor for advice before taking ketoconazole within 15 weeks of taking Lariam
- rifampicin (used to treat bacterial infections ) and efavirenz ( HIV medicines)
- medicines for coagulation disorders or diabetes because your doctor may want to follow up before you travel.
If you need a vaccine taken as a drink to prevent typhoid fever, you should take it at least 3 days before you start taking Lariam. Otherwise, Lariam may weaken the effect of the vaccine.
Taking Lariam with food and drink:
Drink plenty of fluids and preferably take the tablets with meals. Avoid chewing the tablets as they taste bad. The tablets can be crushed.
Pregnancy and breastfeeding
It is not recommended that you travel to a malaria area if you are pregnant, think you may be pregnant, or are planning to become pregnant as malaria is a serious illness during pregnancy.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Lariam should be avoided if possible during pregnancy, but can in special cases be taken throughout pregnancy. Your doctor will decide if you should receive this medicine.
Breast-feeding is not recommended when using Lariam.
Driving and using machines
Caution should be exercised concerning activities that require sharpness and fine motor skills such as driving vehicles and/or aircraft (eg pilots), use of machinery, and deep-sea diving, as Lariam may cause dizziness, imbalance, or mental health.
In a small number of patients, it has been reported that dizziness, vertigo, or balance disorders may persist for months or longer after the end of treatment. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Lariam
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. In case of occurrence of certain symptoms during prophylaxis, see the last paragraph under “Take special care with Lariam”, the treatment must be stopped, in other cases you should never change the prescribed dose yourself without consulting your doctor.
Preventive treatment
The usual dose for adults: 1 tablet per week. The medication should start if possible 3 weeks but at least 1 week before arrival in the malaria-affected area, continue during the stay, and 4 weeks after returning home. Always take the weekly dose on the same day of the week. If vomiting within 30 minutes after taking the tablet, take another tablet. If vomiting occurs 30-60 minutes after taking the tablet tas tablet.
Children: The dose should be determined by a doctor.
Treatment of diagnosed malaria
Dose one should be determined by a physician. You may be instructed to divide the total dose into 2 to 3 smaller doses given at 6-8 hour intervals to reduce the risk of side effects.
In partially immune individuals, such as residents of malaria-affected areas, the standard dose should be given.
If you take more Lariam than you should:
If you take too many tablets, the risk of side effects and the severity of side effects listed in section 4 may increase. There are no specific antidotes.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Undesirable effects occur more often when Lariam is used to treat diagnosed malaria than when the medicine is given as a preventive treatment.
Lariam can cause serious mental conditions in some patients. Talk to your doctor immediately if you get any of the following while using Lariam. Lariam treatment should then be stopped immediately and replaced with another malaria prophylaxis medicine.
Very common (may affect more than 1 user in 10):
- sleep problems (abnormal dreams / nightmares, difficulty falling asleep)
Common (may affect up to 1 in 10 people):
- Depression
- severe anxiety
Has been reported (occurs in an unknown number of users):
- suicide
- suicide attempt
- suicidal thoughts
- self-harming behavior
- bipolar disease
- lose touch with reality ( psychosis including delusions, personality change, mania and schizophrenia)
- feelings of distrust of others
- deviant behavior
- panic attacks
- confusion
- see or hear things that do not exist (hallucinations)
- new or worsened feeling of being angry (aggression)
- disorders in the coordination of movements
- restlessness
- mood swings
- concentration disorders
If you get any of the following potentially serious symptoms, seek medical attention immediately. It is important that you then have information about your medication.
Has been reported (occurs in an unknown number of users):
- a severe, potentially life-threatening allergic reaction (allergic shock ) with symptoms such as difficulty breathing, swollen tongue, itching and severe skin rash.
- seizures ( epilepsy or convulsions).
- heart problems e.g. severe heart rhythm disturbances including throbbing, tearing or skipped heartbeats ( palpitations ).
- an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals (Stevens Johnson syndrome, erythema multiforme).
- pneumonia , also called pneumonia . This is a serious, potentially life-threatening allergic reaction in the lungs that can cause fever or chills, cough and breathing problems.
- severe liver problems with symptoms such as a sore, hard or enlarged liver, jaundice (yellowed skin tone / yellowing of the whites of the eyes), dark urine, light stools and general itching .
- Lariam can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general condition or fever with local infection symptoms such as sore throat / pharynx / mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ) .
Other possible side effects are
Common (may affect up to 1 in 10 people):
- dizziness
- headache
- visual disturbances
- balance disorders
- feeling sick (nausea)
- diarrhea
- stomach pain (abdominal pain)
- vomiting
- itching
Has been reported (occurs in an unknown number of users):
- abnormal blood counts showing decreased or increased white blood cell count , decreased red blood cell count or platelets . Symptoms may include painful cold sores or sores in the throat, fever, chills, bruising, nosebleeds, bleeding in the stomach or vaginal bleeding.
- renal impairment causes deterioration or stopping of urine formation, infection in the urinary tract, blood in the urine. Symptoms may include abnormal blood levels (elevated creatinine value), feeling of dehydration, fatigue, swelling ( edema ), shortness of breath, malaise, loss of appetite, headache.
- decreased appetite
- forgetfulness, memory loss (sometimes prolonged)
- fainting
- speech difficulties
- neuropathy with symptoms such as numbness and tingling, weakness, added or aggravated instability in the feet or balance disorders or shaking of hands and fingers
- somnolence
- photosensitivity in the evenings or other visual disturbances, blurred vision
- altered hearing including tinnitus or hearing loss
- changes in blood pressure or disturbed heart rhythm
- hot flashes
- shortness of breath
- cough
- breathing problems
- hepatic impairment, hepatitis ( hepatitis ), increase in liver enzymes (seen on blood tests)
- rash
- reddening of the skin
- hair loss
- sweating
- muscle weakness
- muscle cramps
- muscle aches
- joint pain
- skin swelling ( edema )
- chest pain
- impotence
- fatigue
- fever or chills
If you experience these or other side effects during treatment, tell your doctor.
Some side effects may occur after you stop taking Lariam. In a small number of patients, it has been reported that depression, dizziness or vertigo, and balance disorders may persist for months or longer even after treatment is stopped.
How to store Lariam
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is mefloquine 250 mg per tablet.
- The other ingredients are lactose monohydrate 50.6 mg, poloxamer, microcrystalline cellulose, corn starch, crospovidone, ammonium calcium alginate, talc and magnesium stearate.
What the medicine looks like and the contents of the pack
The tablet is round and flat with beveled edges, white to off-white, 12.1 mm in diameter and 3.7 mm thick, with LA-RI-AM-CP embossed on one side and with break grooves on both sides. The tablet can be divided into four equal doses.
Lariam is supplied in blister packs containing 8 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 – 24
17489 Greifswald
Germany