1. Name of the medicinal product

Folic Acid Tablets BP 5 mg Taj Pharma

2. Qualitative and quantitative composition

Each Uncoated Tablet Contains:
Folic Acid BP?????????????????????? 5mg
Excipients????????????????????????????? q.s

For excipients, see Section 6.1.

3. Pharmaceutical form

Tablet

4. Clinical particulars

4.1 Therapeutic indications

Folic Acid is necessary for the normal production and maturation of blood cells and is used in the treatment of nutritional megaloblastic anaemias e.g., megaloblasticanaemia following gastrectomy and the megaloblasticanaemia of pregnancy.

It may also be used prophylactically in chronic haemolytic states or in renal dialysis.

4.2 Posology and method of administration

ADULTS

For nutritional megaloblasticanaemia a dose of 1 tablet daily for up to 4 months is normally sufficient but up to 15 mg daily may be required where malabsorption exists.

A maintenance dose of 5 mg every 1 to 7 days may also be required.

CHILDREN

In children over 1 year the dose is as for adults. (See BNF 25).

Administration ? Oral.

4.3 Contraindications

Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency. This can be untreated pernicious anaemia or other cause of cobalamin deficiency, including lifelong vegetarians. In elderly people, a cobalamin absorption test should be done before long-term folate therapy. Folate given to such patients for 3 months or longer has precipitated cobalamin neuropathy. No harm results from short courses of folate.

Folic acid should never be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B₁₂?deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord.

Folic acid should not be used in malignant disease unless megaloblasticanaemia owing to folate deficiency is an important complication.

Known hypersensitivity to folic acid or any of the excipients.

4.4 Special warnings and precautions for use

Patients with vitamin B₁₂?deficiency should not be treated with folic acid unless administered with adequate amounts of hydroxocobalamin, as it can mask the condition but the subacute irreversible damage to the nervous system will continue. The deficiency can be due to undiagnosed megaloblasticanaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown aethiology or other cause of cobalamin deficiency, including lifelong vegetarians.

Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.

This product is not intended for healthy pregnant women where lower doses are recommended, but for pregnant women with folic acid deficiency or women at risk for the reoccurrence of neural tube defect.

Folic Acid Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactosemalabsorption should not take this medicine.

Folic Acid Tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosemalabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

There is a specific interaction between phenytoin and folate such that chronic phenytoin use produces folate deficiency. Correction of the folate deficiency reduces plasma phenytoin with potential loss of seizure control. Similar but less marked relationship exist with all anti-convulsant treatments including sodium valproate, carbamazepine and the barbiturates. Sulphasalazine and triamterene also inhibit absorption.

Antibacterials, chloramphenicol and co-trimoxazole, may interfere with folate metabolism.

Folate supplements enhance the efficacy of lithium therapy. Methotrexate and trimethoprim are specific anti-folates and the folate deficiency caused by their prolonged use cannot be treated by Folic Acid Tablets BP. Folinic acid should be used. Nitrous oxide anaesthesia may cause an acute folic acid deficiency. Both ethanol and aspirin increase folic elimination.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no known hazards to the use of folic acid in pregnancy, supplements of folic acid are often beneficial.

Non-drug – induced folic acid deficiency, or abnormal folate metabolism, is related to the occurrence of birth defects and some neural tube defects. Interference with folic acid metabolism or folate deficiency induced by drugs such as anticonvulsants and some antineoplastics early in pregnancy results in congenital anomalies. Lack of the vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.

Lactation

Folic acid is actively excreted in human breast milk. Accumulation of folate in milk takes precedence over maternal folate needs. Levels of folic acid are relatively low in colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.

4.7 Effects on ability to drive and use machines

No effect on concentration and co-ordination.

4.8 Undesirable effects

Gastrointestinal disorders Rare (?1/10,000 til<1/1,000)	Anorexia, nausea, abdominal distension and flatulence
Immune system disorders Rare (?1/10,000 til<1/1,000) Not known (frequency cannot be estimated from the available data)	Allergic reactions, comprising erythema, rash, pruritus, urticaria, dyspnoea, and shock. Anaphylactic reaction

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

There are no specific symptoms of overdosage and similarly no emergency treatment or antidotes, metabolisation and excretion can be rapid.

5. Pharmacological properties

5.1 Pharmacodynamic properties

folic acid and derivatives.

Folic acid is a member of the vitamin B group which is reduced in the body to tetrahydrofolate, a co-enzyme active in several metabolic processes and produces a haemopoietic response in nutritional megaloblasticanaemias (but see warning in Section 4.4 regarding need for concomitant use of hydroxycobalamin).

Folic acid is rapidly absorbed and widely distributed in body tissues.

5.2 Pharmacokinetic properties

Absorption ? folic acid is rapidly absorbed from the gastrointestinal tract, mainly from the proximal part of the small intestine. Dietary folates are stated to have about half the bioavailability of crystalline folic acid. The naturally occurring folatepolyglutamates are largely deconjugated and reduced by dihydrofolatereductase in the intestine to form 5-methyltetrahydrofolate (5MTHF). Folic acid given therapeutically enters the portal circulation largely unchanged, since it is a poor substrate for reduction by dihydrofolatereductases.

Distribution ? via portal circulation. 5MTHF from naturally occurring folate is extensively plasma bound. The principal storage site of folate is in the liver; it is also actively concentrated in the CSF. Folate is distributed into breast milk.

Metabolism ? therapeutically given folic acid is converted into the metabolically active form 5MTHF in the plasma and liver. There is an enterohepatic circulation for folate.

Elimination ? Folate metabolites are eliminated in the urine and folate in excess of body requirements is excreted unchanged in the urine. Folic acid is removed by haemodialysis.

5.3 Preclinical safety data

There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SPC.

6. Pharmaceutical particulars

6.1 List of excipients

Lactose granules (consisting of Lactose, Pregelatinised Starch and Sucrose), Stearic acid.

6.2 Incompatibilities

None known.

6.3 Shelf life

3 Years

6.4 Special precautions for storage

Do not store above 25?C.

6.5 Nature and contents of container

PVC/Aluminium Blister Pack.

Pack Size: 7, 14, 28, 30, 50, 90, 100 and 500 tablets.

Not All Packs May Be Marketed.

6.6 Special precautions for disposal and other handling

Folic Acid Tablets BP 5 mg are for oral administration only.

Always read instructions on the label and the Patient Information Leaflet (PIL) enclosed.

Keep all medicines out of the reach of children.

Do not use after the expiry date.

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

Folic Acid Tablets BP 5 mg Taj Pharma
(Folic Acid)

Patient Leaflet: Information for 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

 

• What Folic Acid tablets are and what they are used for
• What you need to know before you take Folic Acid tablets
• How to take Folic Acid tablets
• Possible side effects
• How to store Folic Acid tablets
• Contents of the pack and other information

 

1. What Folic Acid tablets are and what they are used for:

Folic Acid belongs to the vitamin B group. Folic Acid tablets may be used:

to treat:

• folate deficiency anaemia caused by poor diet, poor absorption of food (such as in coeliac disease or a digestive disorder called sprue) or increased use of folate in the body (as in pregnancy)

to prevent:

• folate deficiency caused by some medicines (e.g. those used to treat epilepsy such as phenytoin, phenobarbital and primidone)
• folate deficiency caused by long-term red blood cell damage or kidney dialysis
• neural tube defects in babies (e.g. spina bifida), where women are at risk of having an affected child.

  2. What you need to know before you take Folic Acid tablets

Do not take Folic Acid tablets and tell yourdoctor if you have:

• an allergy (hypersensitivity) to folic acid or any of the other ingredients in the tablets (see section 6)
• an untreated vitamin B₁₂deficiency such as in certain anaemias and lifelong vegetarians
• pernicious anaemia(a form of anaemia causedby lack of vitamin B₁₂ ) or another condition caused by vitamin B₁₂ deficiency
• amalignant (cancerous) disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Folic Acid tablets if you:

• have a folate dependent tumour
• are pregnant
• have any disease that reduces the amount ofvitamin B₁₂in the body.

Other medicines and Folic Acid tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

• antiepileptics (to treat epilepsy) such as phenytoin, phenobarbital, primidone, sodium valproate and carbamazepine
• antibacterials (to treat infections) such as trimethoprim, chloramphenicol and co-trimoxazole
• sulfasalazine (to treat ulcerative colitis, Crohn?s disease or rheumatoid arthritis)
• methotrexate (to treat Crohn?s disease, psoriasis or rheumatoid arthritis)
• lithium for mental health problems
• triamterene, a diuretic (or ?water tablet?)
• a gas and air mixture to put you to sleep for an operation or to relieve pain while you are awake
• alcohol
• aspirin for pain relief or to thin your blood.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast feeding, ask your doctor or pharmacist for advice before taking any medicine.

Folic Acid tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Folic Acid tablets

Always take Folic Acid tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets with water.

Doses:

Adults (including the elderly):

• To treat folate deficiency anaemia

5mg a day for 4 months, which may be increased up to a maximum of 15mg a day.

• To prevent folate deficiency caused by some medicines:

5mg a day for 4 months, which may be increased up to a maximum of 15mg a day.

• To prevent folate deficiency caused by long-term red blood cell damage or kidney dialysis:

5mg every 1-7 days.

• To prevent neural tube defects in babies, where women are at risk of having an affected child: 5mg a day started before conception and continued throughout the first three months.
• To treat folate deficiency during pregnancy: 5mg a day continued to birth.

Use in children and adolescents:

For young children a more suitable form of the medicine should be used.

• To treat folate deficiency anaemia:

Children 1-18 years old: 5mg a day for 4 months. The maintenance dose is 5mg every 1-7 days.

• To treat haemolyticanaemia and metabolic disorders:

Children 1-12 years old: 2.5mg-5mg once a day.

Children 12-18 years old: 5-10mg once a day.

• To prevent folate deficiency in kidney dialysis: Children 1-12 years old: 250micrograms per kg of body weight (up to a maximum of 10mg) once a day. Children 12-18 years old: 5-10mg once a day.

If you take more than you should

If you (or someone else) swallow a lot of the tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take the tablets

If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Folic Acid tablets can cause side effects, although not everybody gets them.

Tell your doctor if you notice any of the following sideeffects, they get worse or you notice any not listed:

Rare (May affects upto 1 in 1000 Peoples)

• Allergic reaction (hypersensitivity) e.g. itchy/red skin,rash.
• Severe allergic reaction (anaphylactic reaction) ?swelling of the face, lips, tongue or throat or difficulty breathing or swallowing, shock (cold sweaty skin, weak pulse, dry mouth, dilated pupils).
• Stomach and intestines: loss of appetite, feeling sick,a bloated feeling, wind.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Folic Acid tablets

Keep out of the sight and reach of children.

Store below 25?C in a dry place.

Protect from light.

Do not use Folic Acid tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Folic Acid tablets contain

Each Uncoated Tablet Contains:
Folic Acid BP?????????????????????? 5mg
Excipients????????????????????????????? q.s

The other ingredients are colloidal silica, lactose, maize starch, magnesium stearate.

PVC/Aluminium Blister Pack.

Pack Size: 7, 14, 28, 30, 50, 90, 100 and 500 tablets.

Not All Packs May Be Marketed.

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