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Macdech Proguanil Tablets

NAFDAC Reg. No. B4-7418 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Macdech Proguanil Tablets
NAFDAC number
B4-7418
Active ingredient
Proguanil (Proguanil Hydrochloride)
Strength
100 mg
Form
Tablet
Pack size
1 x 100's (in HDPE bottles)
Manufacturer
Not listed
Applicant (holder)
Macdech Pharmaceuticals Company Limited
Approved
26 Jan 2023
Status
Active View on NAFDAC ↗
Registration valid to
25 Jan 2028
WHO alerts
None found
Community reports
None
Times checked
0

What we found

  • Macdech Proguanil Tablets is on the NAFDAC register with an active registration (B4-7418). 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 Macdech Proguanil Tablets is used for

From the official U.S. FDA label for proguanil (proguanil hydrochloride), the active ingredient registered with NAFDAC.

What it is used for

Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. …

Possible side effects

The following clinically significant adverse reactions are discussed in another section of the labeling: • Vomiting and Diarrhea [see Warnings and Precautions ( 5.1 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.3 )]. • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )]. • Prophylaxis: Common adverse reactions (≥4%) in adults were diarrhea, dreams, oral ulcers, and headache; these events occurred in a similar or lower proportion of subjects receiving atovaquone and proguanil hydrochloride than an active comparator. Common adverse reactions (≥5%) in pediatric patients included abdominal pain, headache, cough, and vomiting. …

Do not use if

• Known serious hypersensitivity reactions to atovaquone or proguanil hydrochloride or any component of the formulation. ( 4 ) • Prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance

Warnings

• Atovaquone absorption may be reduced in patients with diarrhea or vomiting. If used in patients who are vomiting, parasitemia should be closely monitored and the use of an antiemetic considered. In patients with severe or persistent diarrhea or vomiting, alternative antimalarial therapy may be required. ( 5.1 ) • In mixed P. falciparum and Plasmodium vivax infection, P. vivax relapse occurred commonly when patients were treated with atovaquone and proguanil hydrochloride alone. ( 5.2 ) • In the event of recrudescent P. falciparum infections after treatment or prophylaxis failure, patients should be treated with a different blood schizonticide. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes . …

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

Check your pack of Macdech Proguanil Tablets

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 Macdech Proguanil Tablets

What is in Macdech Proguanil Tablets?

Macdech Proguanil Tablets contains Proguanil (Proguanil Hydrochloride) (100 mg), as tablet, according to its NAFDAC registration record.

Is Macdech Proguanil Tablets registered with NAFDAC?

Yes. Macdech Proguanil Tablets is listed on the NAFDAC register under registration number B4-7418, and its registration is active as of 28 October 2026.

Has Macdech Proguanil Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Macdech Proguanil Tablets in our automatically synced alert list.

How can I check that my pack of Macdech Proguanil Tablets is genuine?

Run a free authenticity scan with the NAFDAC number B4-7418, 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 Macdech Proguanil Tablets used for?

Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falcipa (Summarised from the official U.S. FDA label for proguanil (proguanil hydrochloride). Always follow your doctor or pharmacist.)

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