LARIAM 250MG Tablets

Lariam tablets contain the active ingredient mefloquine. Lariam is used to treat malaria and to help prevent you from catching malaria.

Malaria is a life threatening disease and a major health risk for travellers visiting tropical countries.

It occurs when small parasites are passed from one person to another by the bites of certain mosquitoes. Lariam is especially useful if you are travelling to countries where there is a type of malaria which is particularly difficult to treat. No single medicine is effective against all malaria parasites. The choice of a particular medicine depends on the sensitivity of the malaria parasites found in the area to be visited. Your doctor will advise you whether Lariam is suitable for the area to which you wish to go.

To help minimise your chance of catching the disease and to protect you from possible serious side effects it is important that you read this leaflet carefully. Ask your doctor to explain anything you do not understand.

What you need to know before you take Lariam

Malaria prevention

Please read the following section if you are taking the tablets to help prevent you from catching malaria.

Important

• Take the tablets once a week, always on the same day.
• Take the 1^st dose 10 days before you leave: this is to make sure that Lariam is well tolerated. Take the 2^nd dose 3 days before you leave.
• Continue taking the tablets on the same day of the week throughout your stay and for 4 weeks after your return.
• The full course of tablets is at least 6 weeks, depending on your length of stay.
• For effective prevention you must take the full course of tablets.
• No anti-malarial tablets can be 100% guaranteed to work. There is a chance you could still get malaria during or after taking medicine to prevent it. If you develop a fever or flu-like symptoms during your travels or within 2 to 3 months after you leave the malarious area, check with a doctor immediately.

Adults and children over 45 kg body weight, dose:

One tablet weekly (always on the same day).

A pack of 8 tablets is enough to help prevent you from catching malaria if you are staying for 2 weeks in an area where malaria is present and you start taking the tablets at 10 days and 3 days before departure.

Adults weighing less than 45 kg (99 lbs) should take the children’s dose (see below).

Whether you are an adult or a child you should not take the tablets for more than 12 months.

Childrens dose:

The tablets are not recommended for children under 3 months of age, i.e., those who weigh less than 5 kg (11 lbs). For children over this weight, the dose is shown in the table below. The tablets can be divided by breaking along the score lines. As in adults, the dose should be taken once weekly on the same day, and continued for 4 weeks after return.

For children of an approximate age of 3 months to 5 years, weighing between 5-19 kg (11-43 lbs) the recommended dose is ¼ tablet.

For children of an approximate age of 6 to 8 years, weighing between 20-30 kg (44-67 lbs) the recommended dose is ½ tablet.

For children of an approximate age of 9 to14 years, weighing between 31-45 kg (68-99 lbs) the recommended dose is ¾ tablet.

Malaria treatment

Please read the following section if you are taking the tablets to treat malaria.

Your doctor will tell you how much medicine you need to take. This will depend on your weight and whether you have been living in a malarious area. Normally, you should not receive more than 6 tablets in total. You may be advised to split the total dose into 2 or 3 smaller doses, 6 - 8 hours apart, to reduce the likelihood or severity of side effects.

If you take more Lariam than you should, either for prevention or treatment

If you take too many tablets the likelihood and severity of the side effects as described in section 4 may increase. There are no specific antidotes.

If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital immediately.

If you forget to take Lariam, either for prevention or treatment

If you miss a dose, take it as soon as possible. If it is nearly time for your next dose, skip the missed dose and carry on as before. Do not take a double dose.

Lariam may cause serious mental problems in some people. Stop taking this medicine and contact your doctor immediately if you experience any of the following while taking Lariam:

Common (may affect up to 1 in 10 people):

• severe anxiety
• depression

Not known (frequency cannot be estimated from the available data):

• suicide
• attempted suicide
• suicidal thoughts
• self-endangering behaviour
• losing touch with reality (psychosis)
• panic attacks
• feelings of mistrust towards others (paranoia)
• seeing or hearing things that are not there (hallucinations)
• feeling restless
• unusual behaviour
• feeling confused
• unusual changes in your mood
• agitation
• new or worsening feeling of anger (aggression)
• disturbance in attention

Please seek medical help immediately if you experience serious mental problems while taking Lariam. Lariam should be stopped immediately and replaced with another medicine to prevent malaria.

If you develop any of the following potentially serious symptoms, you should STOP taking this medicine and also consult a doctor immediately.

Not known (frequency cannot be estimated from the available data):

• a mild to serious potential life-threatening allergic reaction (anaphylaxis) to Lariam or any of its ingredients with symptoms such as difficulty in breathing, swollen tongue, itching and severe rash
• severe changes in texture and appearance of the skin, especially if it affects your mouth and eyes (Stevens Johnson syndrome)
• fits (seizures or convulsions)
• heart problems e.g. severe changes in heartbeat, including pounding, racing or skipped beats (palpitations)
• inflammation of the lungs, also known as pneumonitis. This is a serious, potentially life-threatening allergic reaction in the lungs which may cause fever, chills, cough, shortness of breath or chest pain.
• severe liver problems which might be demonstrated by a transient increase in your liver enzymes shown by blood tests or other symptoms such as tender, firm or possibly enlarged liver, jaundice (yellowing of skin/eyes), dark urine, light coloured stools and generalised itchiness

Other possible side effects

Very common (may affect more than 1 in 10 people):

• sleeping problems (sleepiness, unable to sleep, bad dreams)

Common (may affect up to 1 in 10 people):

• dizziness
• headache
• problems with your vision
• loss of balance (vertigo)
• feeling sick (nausea), being sick (vomiting)
• diarrhoea
• stomach ache (abdominal pain)
• itching

Not known (frequency cannot be estimated from the available data):

• abnormal blood test results showing a decrease or an increase in white blood cells, a decrease in red blood cells or platelets. Symptoms may include painful mouth or throat ulcers, fever, chills, bruises on the skin, nosebleeds, bleeding in the stomach or vaginal bleeding.
• kidney problems, failure or infection, causing impairment, cessation , infection, or blood in the urine. Symptoms may include abnormal blood tests, feeling dehydrated, fatigue, swelling (oedema), shortness of breath, feeling or being sick, loss of appetite, or headache
• decreased appetite
• forgetfulness (sometimes lasting for more than 3 months)
• fainting
• neuropathy with signs of e.g. “pins and needles”, weakness, new or worsening clumsiness or unsteadiness on your feet, or shaking of the hands and fingers
• difficulties in talking
• difficulties with sense of smell and taste, eye movement, facial sensation and expression, hearing, balance, tasting, tongue movement, head-turning, and raising your shoulders
• cataract, blurred vision, dazzled in the evenings or other vision disturbances
• changes to your hearing including ringing in the ears or difficulty in hearing (sometimes prolonged), everyday sounds seeming too loud
• changes to blood pressure or heart rate
• hot flushes
• breathlessness, cough
• indigestion
• pancreas problems; symptoms may include stomach pain, nausea, vomiting, changes to blood pressure or heart rates and breathlessness
• rash
• hair loss
• sweating
• muscle weakness
• muscle cramps
• joint pains
• muscle pains
• oedema
• chest pain
• tiredness
• fever or chills

Whilst taking this medicine, if you experience these or any other symptoms that concern you, tell your doctor.

Some side effects may occur after you have stopped taking Lariam. In a small number of patients it has been shown that depression, dizziness or vertigo and loss of balance may persist for months or longer, even after you have stopped taking Lariam.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.