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Zedmatem Softgel 80/480 mg Capsules

NAFDAC Reg. No. A4-101190 · Drug

Registered with NAFDAC. Registration activeAs of 27 October 2026 · synced automatically from official sources.
Product
Zedmatem Softgel 80/480 mg Capsules
NAFDAC number
A4-101190
Active ingredient
Artemether; Lumefantrine
Strength
80 mg; 480 mg
Form
Capsule
Pack size
1 x 6's (in Alu-Alu blister)
Manufacturer
Not listed
Applicant (holder)
ZMC International Limited
Approved
30 Jan 2025
Status
Active View on NAFDAC ↗
Registration valid to
29 Jan 2030
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Zedmatem Softgel 80/480 mg Capsules is on the NAFDAC register with an active registration (A4-101190). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Zedmatem Softgel 80/480 mg Capsules is used for

From the official U.S. FDA label for artemether, the active ingredient registered with NAFDAC.

What it is used for

Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. …

Possible side effects

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4)] Prolongation of the QT Interval [see Warnings and Precautions (5.1)] Use of QT Prolonging Drugs and Other Antimalarials [see Warnings and Precautions (5.2)] Drug Interactions with CYP3A4 [see Warnings and Precautions (5.3)] Drug Interactions with CYP2D6 [see Warnings and Precautions (5.4)] The most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia. …

Do not use if

Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)] . Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. …

Warnings

Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval. ( 5.1 , 12.6 ) Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. ( 5.1 , 5.2 , 12.3 ) Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data. ( 5.2 ) QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Zedmatem Softgel 80/480 mg Capsules

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Zedmatem Softgel 80/480 mg Capsules

What is in Zedmatem Softgel 80/480 mg Capsules?

Zedmatem Softgel 80/480 mg Capsules contains Artemether; Lumefantrine (80 mg; 480 mg), as capsule, according to its NAFDAC registration record.

Is Zedmatem Softgel 80/480 mg Capsules registered with NAFDAC?

Yes. Zedmatem Softgel 80/480 mg Capsules is listed on the NAFDAC register under registration number A4-101190, and its registration is active as of 27 October 2026.

Has Zedmatem Softgel 80/480 mg Capsules been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Zedmatem Softgel 80/480 mg Capsules in our automatically synced alert list.

How can I check that my pack of Zedmatem Softgel 80/480 mg Capsules is genuine?

Run a free authenticity scan with the NAFDAC number A4-101190, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Zedmatem Softgel 80/480 mg Capsules used for?

Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets ar (Summarised from the official U.S. FDA label for artemether. Always follow your doctor or pharmacist.)

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