1. Name of the Medicinal Product
Ginkgo biloba tablets 40mg Taj Pharma
2. Qualitative and Quantitative Composition
Each film coated tablet contains:
Dried extract of Ginkgo Biloba BP 40mg
(Contains 9.6mg of Ginkgo Flavones Glycoside)
Colours: Tartrazine and Titanium Dioxide USP.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet.
4. Clinical Particulars
Therapeutic indications
A traditional herbal medicinal product used to relieve the symptoms of Raynaud’s syndrome and tinnitus, based on traditional use only.
Posology and method of administration
Adults and the elderly: One tablet twice daily after food increasing to two tablets twice daily if necessary.
Children and adolescents less than 18 years old:
The use in children and adolescents under 18 years of age is not recommended (see Section 4.4).
Duration of use:
If the symptoms worsen or persist for more than 4 weeks a doctor or a qualified healthcare practitioner should be consulted.
For oral use only.
Contraindications
Do not use in cases of known hypersensitivity to Ginkgo preparations or to any of the excipients.
This product contains soya polysaccharide. If you are allergic to peanut or soya, do not take this product. Refer to Section 2, for soya polysaccharide content.
Special warnings and precautions for use
The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
Keep out of the reach and sight of children.
There are rare case reports of spontaneous bleeding in association with the use of products containing Ginkgo extracts. Although no causal link has been established care should be taken by patients who have a pre-existing bleeding disorder. It is advisable that Ginkgoforce tablets are discontinued at least 2 weeks prior to surgery or that clotting parameters are assessed prior to surgery.
Interaction with other medicinal products and other forms of interaction
Appropriate studies have not been conducted to determine whether drug interactions occur with
Ginkgoforce and its active constituents.
Pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been undertaken.
Undesirable effects
The following adverse reactions have rarely been reported in association with the use of products containing Gingko extract.
Body as a whole – general disorders
- Allergy
Central and peripheral nervous system disorders
- Headache
Gastrointestinal system disorders
- Nausea
- Vomiting
- Diarrhoea
Skin and appendages
- Pruritis
- Rash
There have been very rare case reports of Stevens-Johnson syndrome associated with the use of Ginkgo extract.
There are sporadic case reports of bleeding disorders in patients who have been taking preparations containing Ginkgo extract. The causality in these cases is not established.
Overdose
No case of overdose has been reported.
5. Pharmacological properties:
Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
Preclinical safety data
The preclinical toxicology data available are limited.
An in vitro study has shown the aqueous ethanolic Ginkgo extract used in this product to be non-mutagenic in the Salmonella typhimurium reverse mutation assay up to the dose of 5,000 µg/plate.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6. Pharmaceuticals Particulars:
List of excipients: Microcrystalline cellulose, Magnesium stearate, Soya polysaccharide
Incompatibilities
Not applicable.
Shelf life
36 months
Special precautions for storage
Store in the original container.
Nature and contents of container
Aluminium Blister Packs.
Pack Size of: 7, 14, 28, 30, 50, 100 and 500 tablets.
Special precautions for disposal
No special requirements
7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com
Ginkgo biloba Tablets 40mg Taj Pharma
Package leaflet: Information for the user
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What is Ginkgo biloba and what it is used for
2. What you need to know before you take Ginkgo biloba
3. How to take Ginkgo biloba
4. Possible side effects
5. How to store Ginkgo biloba
6. Contents of the pack and other information
- What Ginkgo biloba is and what it is used for
Circulation and memory loss due to brain conditions such as stroke, Alzheimer disease, and dementia. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.
Ginkgo biloba is an herbal product. It works by increasing blood flow to the brain.
Do NOT use GINKGO BILOBA if: You are allergic to any ingredient in ginkgo biloba
Contact your doctor or health care provider right away if any of these apply to you.
- What you need to know before you take Ginkgo biloba
Some medical conditions may interact with ginkgo biloba. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines food or other substances
if you have history of bleeding disorders.
Some MEDICINES MAY INTERACT with ginkgo biloba. Tell your health care provider if you are taking any other medicines, especially any of the following:
Nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., aspirin, ibuprofen) or warfarin because the risk of serious bleeding may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if ginkgo biloba may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
- How to take Ginkgo biloba
Use ginkgo biloba as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Dosing depends on the use and the source of the product.
Use as directed on the package, unless instructed otherwise by your doctor.
If you miss taking a dose of ginkgo biloba for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.
Ask your health care provider any questions you may have about how to use ginkgo biloba.
4.Possible side effects
Some side effects of Ginkgo Biloba may not be reported. Always consult your doctor or healthcare specialist for medical advice.
Applies to ginkgo: oral capsule, oral tablet
Although uncommon, serious side effects have been reported with the use of ginkgo (the active ingredient contained in Ginkgo Biloba) If you experience any of the following serious side effects, stop taking ginkgo and seek emergency medical attention or notify your doctor immediately:
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
irregular heartbeats; muscle spasms or cramps; seizures; or
Loss of consciousness.
Other less serious side effects have also been reported to occur. Talk to your doctor or pharmacist if you experience
headache; dizziness; or Stomach upset.
Do not use ginkgo seeds or fruit pulp. These have been shown to be toxic. Also, do not handle the ginkgo fruit pulp. A severe reaction including skin redness, swelling, blistering, and
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
If OVERDOSE is suspected:
Your local poison control center, or emergency room immediately. Symptoms may include seizures.
- How to store Ginkgo biloba
Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep ginkgo biloba out of the reach of children and away from pets.
- Contents of the pack and other information
The active substance ids Ginkgo Biloba.
Each film coated tablet contains:
Dried extract of Ginkgo Biloba BP 40mg
(Contains 9.6mg of Ginkgo Flavones Glycoside)
Colours: Tartrazine and Titanium Dioxide USP.
Aluminium Blister Packs.
Pack Size of: 7, 14, 28, 30, 50, 100 and 500 tablets.
7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com
A patient information leaflet of Ginkgo Billloba Tablets is a technical document included in every medicine package to offer written information about the medication
