India Product

Aclotol Fast Gel

Aclotol Fast Gel

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
For the relief of the symptoms of cystitis in women.
Posology and method of administration
Adult women
Dissolve the contents of one sachet in a glass of water.
Take orally 1 sachet 3 times per day during 48 hours.
The prepared solution should be used immediately.
Men and children
It is not recommended.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
In isolated cases:
skin rash, abdominal pain.

Когда Вы должны проконсультироваться с вашим врачем ?

Если приближается время для принятия следующей дозы , проигнорируйте пропущенную дозу и примите следующую дозу как вам назначено.
В противном случае , примите дозу сразу , как только Вы вспомнили о ней и далее принимайте как обычно.

Things you MUST NOT DO while on this medicine?

Contraindications
Hypersensitivity to Sodium Citrate and other components of this medicine. It is contraindicated to patients with diabetes, heart disease, artherial hypertension, renal disease or patients who are on a low salt diet.

What to do if you accidentally take too much (overdose) of the medicine?

Overdose
Symptomatic treatment should be used in case of unwanted overdosage of this product.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store below 30°C. Keep out of reach of children.

Drug Description

Each Sachet (5.6gm) Contains:
Sodium Citrate BP……. 4.0 g
For excipients, see section 6.1

Indications and dosage.

Therapeutic indications
For the relief of the symptoms of cystitis in women.
Posology and method of administration
Adult women
Dissolve the contents of one sachet in a glass of water.
Take orally 1 sachet 3 times per day during 48 hours.
The prepared solution should be used immediately.
Men and children
It is not recommended.

Side effects and drug interactions.

Undesirable effects
In isolated cases:
skin rash, abdominal pain.

Interaction with other medicinal products and other forms of interaction
It is unknown.

Warnings and precautions

Special warnings and precautions for use
If symptoms persist after two days of treatment it is necessary to consult a doctor.

Pregnancy and lactation
It is contraindicated during pregnancy and lactation.

Effects on ability to drive and use machines
None stated.

Overdosage and Contraindications

Overdose
Symptomatic treatment should be used in case of unwanted overdosage of this product.

Contraindications
Hypersensitivity to Sodium Citrate and other components of this medicine. It is contraindicated to patients with diabetes, heart disease, artherial hypertension, renal disease or patients who are on a low salt diet.

Clinical pharmacology.

PHARMACEUTICAL FORM
Granules
White-off white, free flowing flavored granules with a pleasant odor.

PHARMACOLOGICAL PROPERTIES
Sodium Citrate is metabolised into bicarbonate, which facilitates regression dysuria, that is observed in cystitis, causing a reduce of urinary acidity causing alkalinization.

Pharmacokinetic properties
None relevant.

Preclinical safety data
None stated.

PHARMACEUTICAL PARTICULARS
List of excipients
Sucrose, Saccharin Sodium and Cranberry Flavour 191121.

Incompatibilities
None stated.

Shelf life
2 years.

Special precautions for storage
Store below 30°C. Keep out of reach of children.

Nature and contents of container
Sodium Citrate Granules packed in a Glassine paper sachets and each sachet contains 5.6 gm of granules. 6 such sachets are enclosed in a carton pack along with pack insert.

MARKETING AUTHORISATION HOLDER
Kusum Healthcare Private Limited
D-158 A, Okhla Industrial Area,
Phase I, New Delhi-110020,
India.

MARKETING AUTHORISATION NUMBER(S)
-------

MANUFACTURER NAME
Kusum Healthcare Private Limited
SP 289 (A), RIICO Industrial Area.
Chopanki, Bhiwadi.
Distt. Alwar - 301707
India
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
-------

DATE OF REVISION OF THE TEXT

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780