|Read all of this leaflet carefully before you start taking MALATEQ Film-coated Tablets: |
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
MALATEQ has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
|1.||WHAT MALATEQ FILM-COATED TABLETS CONTAIN: |
The active substances in each MALATEQ tablet are 250 mg atovaquone and 100 mg proguanil hydrochloride. The other (inactive) ingredients are colloidal silicone dioxide (Aerosil 200), low substituted hydroxypropyl cellulose (L-HPC LH-21), magnesium stearate, microcrystalline cellulose (Apical PH 101), microcrystalline cellulose (Apical PH 102), opadry brown 03C86943, poloxamer 188 (Lutrol F68), povidone (Kollidon 30), purified water and sodium starch glycolate (Primojel).
|2.||WHAT MALATEQ TABLETS ARE USED FOR:|
MALATEQ is indicated for the prevention of Plasmodium falciparum malaria. It belongs to a group of medicines called antimalarials. MALATEQ is used to reduce the risk of contracting malaria caused by Plasmodium falciparum, a parasite. MALATEQ contains two active ingredients which kill the malaria parasites in your body to reduce the risk of contracting malaria.
|3.||BEFORE YOU TAKE MALATEQ TABLETS:|
Do not take MALATEQ tablets
If you are allergic to atovaquone, proguanil hydrochloride or any of the other ingredients of MALATEQ.
If you have severe kidney impairment.
Tell your doctor, pharmacist or healthcare professional before taking MALATEQ if:
you weigh less than 40 kilograms;
you have diarrhoea or are vomiting;
you are taking any medicines containing rifampicin, rifabutin, tetracycline or metoclopramide;
you are taking medicine containing indinavir;
you have problems with your kidneys;
you are pregnant or likely to become pregnant soon; and
you are breastfeeding.
|Before taking MALATEQ, tell your doctor if you are breastfeeding, pregnant or likely to become pregnant soon. |
If you are pregnant or breastfeeding your baby while taking MALATEQ, please consult your doctor, pharmacist or other healthcare professional for advice.
Safety during pregnancy and breastfeeding has not been established. Women breastfeeding their infants should not receive MALATEQ.
|4.||HOW TO TAKE MALATEQ TABLETS:|
|Do not share medicines prescribed for you with any other person. |
Always take MALATEQ exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
|The usual dose is:|
Adults: One MALATEQ tablet daily. In order to prevent malaria, it is important that you take your MALATEQ tablet every day. Start taking 1 or 2 days before travelling to an area, or a country (or countries) where malaria is transmitted. Continue daily dosing while you are there, and for 7 days after returning. MALATEQ tablets should be swallowed whole with a drink. Take the tablets with food or milk, as the active ingredients are then absorbed better from the stomach.
For prevention of malaria, MALATEQ should be taken at the same time each day. In the event of vomiting within one hour of taking a dose, a repeat dose should be taken. In the event of diarrhoea, normal dosing should be continued and personal protection should be used (e.g., repellents, bednets). Your doctor may decide to give you other medicines as well. Please read any instruction leaflet carefully.
Your doctor will tell you how long your treatment with MALATEQ will last. Do not stop treatment because you may increase the risk of contracting malaria. If you have the impression that the effect of MALATEQ is too strong or too weak, tell your doctor or pharmacist.
|It is important to take only the dose of MALATEQ prescribed by your doctor.|
|In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.|
|If you forget to take a dose, take another as soon as possible. Then go on as before. Do not take a double dose to make up for forgotten individual doses.|
|5.||POSSIBLE SIDE EFFECTS:|
|MALATEQ can have side effects. |
Not all side effects reported for MALATEQ are included in this leaflet. Should your general health worsen while taking MALATEQ, please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happen, stop taking MALATEQ and tell your doctor immediately or go to the casualty department at your nearest hospital:
swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing;
rash or itching.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MALATEQ. You may need urgent medical attention or hospitalisation. All of these very serious side effects usually occur less frequently.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
This is a serious side effect. You may need urgent medical attention. Serious side effects usually occur less frequently.
Tell your doctor as soon as possible, if you notice any of the following:
Loss of appetite, feeling sick (nausea) and/or being sick (vomiting), stomach pain, diarrhoea.
Mouth inflammation (swelling, redness, pain) and mouth ulcers.
Allergic reactions including rash, itching and swelling.
Headache, difficulty in sleeping, raised body temperature, hair loss, coughing.
MALATEQ may cause changes to the bodys normal blood levels of certain cells or chemicals or lead to other blood abnormalities. If you are having a blood test for any reason, tell the person who is taking your blood sample that you are receiving MALATEQ, as it may affect your result. While taking MALATEQ, if you feel unwell or have any unusual symptoms, even those that are not mentioned in this leaflet, seek the advice of your doctor or pharmacist.
|6.||STORING AND DISPOSING OF MALATEQ TABLETS:|
|Keep MALATEQ tablets in a safe place where children cannot see or reach it. Your medicine could harm them.|
Keep the medicine in its original container.
Store at or below 25ºC.
Check the use before date shown on the carton at the time of receipt. Do not use it if out of date.
Keep all medicines out of the reach and sight of children. It may harm them.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).
Do not share medicines prescribed for you with others.
|7.||PRESENTATION OF MALATEQ TABLETS:|
|MALATEQ tablets are packed in white HDPE containers with white caps containing 100 tablets. |
MALATEQ tablets are packed in PVC/PVDC (Clear) paper backed with push through Aluminium Foil blister containing 12 tablets.
|8.||IDENTIFICATION OF MALATEQ TABLETS:|
|MALATEQ tablets: Pinkish brown to brown coloured, circular, biconvex bevelled edge film-coated tablets with 404debossed on one side and Gdebossed on the other side.|
|10.||NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:|
|Glenmark Pharmaceuticals South Africa (Pty) Ltd |
Unit 7/8 York House, Tybalt Place
185 Howick Close, Waterfall Office Park,
Bekker Street, Vorna Valley,
|Lamar International (Pty) Ltd |
13 Pasita Street
|12.||DATE OF PUBLICATION:|