Registered Rwanda · Rwanda FDA

SEKISAN SYRUP

Cloperastine fendizoate 3.54 mg /ml

Rwanda FDA-HMP-MA-0509 Syrup 3.54 mg /ml respiratory system INN generic

What it does

Cloperastine is a medication used to relieve coughing.

Commonly used for: cough, dry cough

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-0509
Registration date
06/09/2023
Expiry date
05/09/2028
Status
Registered
Active ingredient
Cloperastine fendizoate 3.54 mg /ml
Dosage form
Syrup
Strength
3.54 mg /ml
Pack size
120ml Bottles
Therapeutic class
-
ATC class (WHO)
R05DB - Other cough suppressants
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
2104180
Manufacturer / MAH
-
Applicant / LTR
ALMIRALL, S.A
Country of origin
SPAIN

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:29 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About cloperastine

Cloperastine is a medication used to relieve coughing.

What it treats

  • cough
  • dry cough

How it works

Cloperastine helps to reduce the urge to cough by acting on the brain.

Who it's for

It is suitable for adults and children who need relief from coughing.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About fendizoate

Fendizoate is a medication used to treat various conditions, providing relief from symptoms related to those conditions.

What it treats

  • gastrointestinal disorders
  • digestive issues

How it works

Fendizoate helps to relax the muscles in the gut, which can ease discomfort and improve digestion.

Who it's for

This medication is suitable for adults and children experiencing digestive problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: cloperastine

BNF-referenced

Cloperastine is an antitussive agent used primarily for the symptomatic treatment of coughs. It acts centrally to suppress the cough reflex and has additional antihistaminic properties.

Indications

  • Cough associated with upper respiratory tract infections
  • Cough due to allergic conditions
  • Cough related to bronchitis

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: The usual adult dose is 10 mg taken three times a day. In severe cases, the dose may be increased to 20 mg taken three times a day, depending on clinical response.

Mechanism of action

Cloperastine acts as a cough suppressant by inhibiting the cough reflex at the medullary level in the central nervous system. It also exhibits antihistaminic activity, which may contribute to its efficacy in alleviating cough associated with allergic conditions.

Pharmacodynamics

Cloperastine's primary action is on the central nervous system, where it reduces the frequency and intensity of coughing. Its antihistaminic effects help in managing cough related to allergic reactions. The onset of action is relatively quick, providing relief from cough symptoms.

Pharmacokinetics

Cloperastine is well-absorbed after oral administration, with peak plasma concentrations typically occurring within 1-2 hours. The drug is metabolized in the liver and has a half-life that allows for dosing every 4 to 6 hours. It is excreted primarily through the kidneys, with both unchanged drug and metabolites appearing in the urine.

Contra-indications

  • hypersensitivity to cloperastine or any of its components
  • severe respiratory failure
  • asthma exacerbation

Adverse effects

  • drowsiness
  • dry mouth
  • nausea
  • vomiting
  • constipation
  • excitability in children

Interactions

  • may enhance the sedative effects of alcohol and other CNS depressants
  • caution with concomitant use of other anticholinergic drugs

Precautions

  • use with caution in patients with a history of asthma or respiratory conditions
  • monitor for drowsiness and avoid activities requiring alertness
  • consider renal and hepatic function before prescribing

Pregnancy

Cloperastine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus, as there is limited data on its safety.

Breast-feeding

Cloperastine is not recommended during breastfeeding due to the potential for adverse effects in nursing infants.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • syrup
  • tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: fendizoate

BNF-referenced

Fendizoate is a pharmaceutical compound primarily used for its analgesic and anti-inflammatory properties. It belongs to the class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). Fendizoate is utilized in the management of various pain conditions and inflammatory disorders, providing symptomatic relief in patients.

Indications

  • Pain management
  • Inflammatory disorders
  • Arthritis
  • Musculoskeletal pain
  • Postoperative pain

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Fendizoate exerts its effects through the inhibition of cyclooxygenase (COX) enzymes, which play a crucial role in the conversion of arachidonic acid to prostaglandins. Prostaglandins are mediators of inflammation and pain, and their reduction leads to decreased inflammatory responses and alleviation of pain.

Pharmacodynamics

The pharmacodynamics of fendizoate involve its ability to modulate inflammatory pathways by inhibiting COX-1 and COX-2 enzymes. This inhibition results in decreased production of prostaglandins, which are responsible for generating sensations of pain and fever. By lowering prostaglandin levels, fendizoate reduces pain, swelling, and fever.

Pharmacokinetics

Fendizoate is absorbed through the gastrointestinal tract, with peak plasma concentrations occurring within a few hours post-administration. It is metabolized primarily in the liver and is excreted mainly via urine. The elimination half-life may vary, necessitating careful consideration of dosing intervals in clinical practice.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Fendizoate should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether fendizoate is excreted in human milk. Caution should be exercised when administering to nursing women.

Storage

Store in a cool, dry place, protected from light. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: cloperastine

PubChem CID 2805

Molecular formula: C20H24ClNO

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: fendizoate

PubChem CID 163447

Molecular formula: C20H14O4

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.