CROCIN PAIN RELIEF
PRODUCT INFORMATION LEAFLET
1. Product Name
Brand Name: Crocin Pain Relief
Generic Name: Acetaminophen and Caffeine Tablets USP
2. Qualitative & Quantitative Composition
Each uncoated tablet contains:
Paracetamol I.P. 650 mg
Caffeine Anhydrous I.P. 50 mg
3. Dosage Form
Oral Uncoated Tablets
4. Clinical Particulars
4.1. Indications/Uses
Crocin Pain Relief contains paracetamol, which is an analgesic and antipyretic, and
caffeine, an adjuvant to the analgesic effect of paracetamol.
Crocin Pain Relief is used for the treatment of mild to moderate pain including,
headache, migraine, toothache, period pain, Pain of osteoarthritis and
musculoskeletal pains.
4.2. Posology and method of administration
Dosage for Adults and children over 12 years: 1 tablet every 4 to 6 hours.
Do not take more frequently than every 4 hours and not more than 6 tablets per 24
hours. Do not exceed the stated dose.
Always use the lowest effective dose to relieve your symptoms.
Crocin Pain Relief is not recommended in children under 12 years of age. Do not
take this medicine more than 3 days without medical advice.
4.3. Contra-indications
Crocin Pain Relief is contraindicated in patients with a previous history of
hypersensitivity to paracetamol, caffeine or any of the other ingredients in the
product.
4.4. Warnings and Precautions
Crocin Pain Relief contains Paracetamol. Taking too much paracetamol can cause
serious harm to your liver. Do not take this medicine if you are taking any other
prescription or non-prescription medicines containing paracetamol to treat pain,
fever, symptoms of cold and flu, or to aid sleep.
Always read and follow the label
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CROCIN PAIN RELIEF
Check with your doctor before use if you:
have liver or kidney problems.
have a severe infection, are severely malnourished, severely underweight or
are a chronic heavy alcohol user as this may increase the risk of metabolic
acidosis. Signs of metabolic acidosis include:
- deep, rapid, difficult breathing,
- feeling sick (nausea), being sick (vomiting),
- loss of appetite.
Contact a doctor immediately if you get a combination of these symptoms.
You may also need to avoid using the product altogether or limit the amount of
paracetamol that you take.
This medicine contains caffeine. Avoid drinking too many caffeine containing
drinks (eg. tea, coffee and caffeine containing canned drinks) when taking this
medicine. High caffeine intake can result in difficulty sleeping, shaking and an
uncomfortable feeling in the chest caused by fluttering heartbeat.
Please see your doctor if your symptoms do not improve.
4.5. Interaction with other medicaments and other forms of interaction
Before taking this medicine, make sure you consult your doctor if you are taking
warfarin or similar medicines used to thin the blood.
4.6. Pregnancy and lactation
Pregnancy: Not recommended for use during pregnancy.
Lactation: Use during breast-feeding should be avoided.
4.7. Effects on ability to drive and use machines, if contra-indicated
None
4.8. Undesirable effects/side effects
Stop taking this medicine and tell your doctor immediately if:
you experience allergic reactions such as skin rash or itching, sometimes with
breathing problems or swelling of the lips, tongue, throat or face.
you experience a skin rash or peeling, or mouth ulcers.
you have previously experienced breathing problems with aspirin or non-steroidal
anti-inflammatory drugs, and experience a similar reaction with this product.
you experience unexplained bruising or bleeding.
These reactions are rare.
4.9. Overdose
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CROCIN PAIN RELIEF
In case of over dosage, seek medical advice from a doctor immediately even if you
do not have any symptoms because of the risk of liver failure.
In case of over dosage, you may also contact the National Poisons Information
Centre of India. Details of the same are as below:
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi-110029
Toll Free No. - 1800 116 117
Tel No.- 26589391, 26593677
5. Pharmacological Properties
5.1. Pharmacodynamic Properties & mechanism of action
ATC code: N02B E01
Pharmacotherapeutic group: Paracetamol: Anilides
Caffeine: Methylxanthine
Paracetamol is an antipyretic and analgesic. Its mechanism of action is believed to
include inhibition of prostaglandin synthesis, primarily within the central nervous
system. The lack of peripheral prostaglandin inhibition confers important
pharmacological properties such as the maintenance of the protective
prostaglandins within the gastrointestinal tract. Paracetamol, is therefore, particularly
suitable for: patients with a history of disease, or patients taking concomitant
medication, where peripheral prostaglandin inhibition would be undesirable (for
example, those with a history of gastrointestinal bleeding or in the
elderly).
Caffeine acts as an analgesic adjuvant which enhances the efficacy of paracetamol.
Clinical data have demonstrated that paracetamol-caffeine provides superior pain
relief compared to standard paracetamol tablets (p<=0.05). Caffeine is a methyl-
xanthine and a non-selective adenosine receptor antagonist.
5.2. Pharmacokinetics
Paracetamol is rapidly absorbed from the gastrointestinal tract and is distributed into
most body tissues. Binding to plasma proteins is minimal at therapeutic
concentrations. Paracetamol is metabolised in the liver and excreted in the urine
mainly as glucuronide and sulphate metabolites - less than 5% is excreted as
unmodified paracetamol. The mean plasma half-life is about 2.3 hours.
Caffeine is rapidly absorbed from the gastrointestinal tract and is widely distributed
throughout the body. Caffeine is almost completely metabolized in the liver by
oxidation and demethylation to various xanthine derivatives, which are excreted in
the urine. The mean plasma half-life after oral administration is about 4.9 hours.
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6. Pharmaceutical Particulars
6.1. List of Excipients
Pregelatinised Maize starch
Maize Starch
Povidone K-25
Croscarmellose Sodium
Potassium Sorbate
Magnesium stearate
Purified Water
6.2. Incompatibilities
Not applicable
6.3. Shelf life
24 months
6.4. Special storage conditions
Keep out of sight and reach of children.
Store at ambient room temperature protected from light and moisture.
6.5. Nature and specification of the container
15 tablets blister (Aluminium/ PVC).
6.6. Instructions for Use and Handling
No special instructions for use and handling.
6.7. Manufacturing License Holder
Remidex Pharma Pvt Ltd.
B- 249/250, Peenya II Stage, Bangaluru 560058, India
6.8. Marketed By
GlaxoSmithKline Asia Private Limited,
Patiala Road, Nabha- 147201, Punjab, India
*Crocin is a trademark owned by or licensed to the GSK Group of companies
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