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Fiflo Capsules

NAFDAC Reg. No. A4-100550 · Drug

Registered with NAFDAC — registration activeAs of 6 November 2026 · synced automatically from official sources.
Product
Fiflo Capsules
NAFDAC number
A4-100550
Active ingredient
Tamsulosin Hydrochloride
Strength
400 mcg
Form
Capsule
Pack size
3 x 10's (in PVC-Alu blisters)
Manufacturer
Not listed
Applicant (holder)
Sai Sagar Pharma Limited
Approved
31 Oct 2023
Status
Active View on NAFDAC ↗
Registration valid to
30 Oct 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • Fiflo Capsules is on the NAFDAC register with an active registration (A4-100550). 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. Not medical advice — always follow your doctor or pharmacist.

What Fiflo Capsules is used for

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

What it is used for

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1)

Possible side effects

The most common adverse events (≥2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia, back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence, nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XLCare Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Do not use if

Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2)] . Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules (4, 6.2)

Warnings

Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur (5.1) Should not be used in combination with strong inhibitors of CYP3A4. Use with caution in combination with moderate inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors. …

Pregnancy & breastfeeding

8.1 Pregnancy Risk Summary Tamsulosin hydrochloride is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [see Data]. …

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

Check your pack of Fiflo Capsules

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Fiflo Capsules

What is in Fiflo Capsules?

Fiflo Capsules contains Tamsulosin Hydrochloride (400 mcg), as capsule, according to its NAFDAC registration record.

Is Fiflo Capsules registered with NAFDAC?

Yes. Fiflo Capsules is listed on the NAFDAC register under registration number A4-100550, and its registration is active as of 6 November 2026.

Has Fiflo Capsules been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Fiflo Capsules in our automatically synced alert list.

How can I check that my pack of Fiflo Capsules is genuine?

Run a free authenticity scan with the NAFDAC number A4-100550, 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 Fiflo Capsules used for?

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (Summarised from the official U.S. FDA label for tamsulosin hydrochloride. Always follow your doctor or pharmacist.)

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