1. NAME OF THE MEDICINAL PRODUCT
Chlorphenamine maleate Tablets USP 4mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains

Chlorphenamine Maleate USP            4mg
Excipients                                             q.s.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Round, circular, biconvex, yellow tablets

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Chlorphenamine maleate tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, insect bites.

Also indicated for the symptomatic relief of itch associated with chickenpox.

4.2  Posology and method of administration
Oral Administration only

Do not exceed the stated dose or frequency of dosing

Adults and children 12 years and over: 1 tablet 4 to 6 hourly. Maximum daily dose: 6 tablets (24 mg) in any 24 hours

Elderly: The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 12 mg in any 24 hours).

Children aged 6 – 12 years: ½ tablet 4 to 6 hourly. Maximum daily dose: 3 tablets (12mg) in any 24 hours
Not recommended for children under 6 years

4.3 Contraindications
Chlorphenamine maleate tablets are contra-indicated in patients who are hypersensitive to antihistamines or to any of the tablet ingredients.

The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Chlorphenamine maleate Tablets is therefore contra-indicated in patients who have been treated with MAOIs within the last fourteen days.

4.4 Special Warnings and precautions for use
Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment; renal impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness).

The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery.

The effects of alcohol may be increased and therefore concurrent use should be avoided.

Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine,

Keep out of sight and reach of children.

4.5 Interaction with other medicinal products and other forms of interaction
Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).

4.6 Fertility, Pregnancy and lactation
Pregnancy
There are no adequate data from the use of chlorphenamine maleate in pregnant women. The potentisl risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essentially by a physician.

Lactation
Chlorphenamine maleate and other antihistamine may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician

4.7 Effects on ability to drive and use machines
The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients’ ability to drive and use machinery.

4.8 Undesirable Effects
Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trails and which are considered to be common (occurring in ≥1% to <10% of subjects) or very common (occurring in ≥10% of subjects) are listed below by MedDRA Sytem Organ Class. The frequency of other adverse reactions identified during post-marketing use is unknown.

Blood and lymphatic system disorders:
Unknown: haemolytic anaemia, blood dyscrasias

Immune system disorders:
Unknown: allergic reaction, angioedema, anaphylactic reactions

Metabolism and nutritional disorders:
Unknown: anorexia

Psychiatric disorders:
Unknown: confusion*, excitation*, irritability*, nightmares*, depression

Nervous system disorders*:
Very common: sedation, somnolence

Common: disturbance in attention, abnormal coordination, dizziness headache

Eye Disorders:
Common: blurred vision

Ear and labyrinth disorders:
Unknown: tinnitus

Cardiac disorders:
Unknown: palpitations, tachycardia, arrythmias

Vascular disorders:
Unnown: Hypotension

Respiratory, thoracic and mediastinal disorders:
Unknown: thickening of bronchial secretions

Gastrointestinal disorders:
Common: nausea, dry mouth
Unknown: vomiting, abdominal pain, diarrhoea, dyspepsia

Hepatobiliary disorders:
Unknown: hepatitis, including jaundice

Skin and subcutaneous disorders:
Unknown: exfoliative dermatitis, rash, urticaria, photosensitivity

Musculoskeletal and connective tissue disorders:
Unknown: muscle twitching, muscle weakness

Renal and urinary disorders:
Unknown: urinary retention

General disorders and administration site conditions:
Common: fatigue
Unknown: chest tightness

*Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness).

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

Symptoms and signs
The estimated lethal dose of chlorphenamine is 25 to 50mg/kg body weight. Symptoms and signs include sedation, paradoxical excitation of the CNS, toxic psychosis, convulsions, apnoea, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.

Treatment
Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently (treatment is most effective if given within an hour of ingestion). Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with i.v. diazepam. Haemoperfusion may be used in severe cases.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Chlorphenamine is a potent antihistamine (H1-antagonist).

Antihistamines diminish or abolish the actions of histamine in the body by competitive reversible blockade of histamine H1-receptor sites on tissues. Chlorphenamine also has anticholinergic activity.

Antihistamines act to prevent the release of histamine, prostaglandins and leukotrienes and have been shown to prevent the migration of inflammatory mediators. The actions of chlorphenamine include inhibition of histamine on smooth muscle, capillary permeability and hence reduction of oedema and wheal in hypersensitivity reactions such as allergy and anaphylaxis.

5.2 Pharmacokinetic properties
Chlorphenamine is well absorbed from the gastro-intestinal tract, following oral administration. The effects develop within 30 minutes, are maximal within 1 to 2 hours and last 4 to 6 hours. The plasma half-life has been estimated to be 12 to 15 hours.

Chlorphenamine is metabolised to the monodesmethyl and didesmethyl derivatives. About 22% of an oral dose is excreted unchanged in the urine.

5.3 Preclinical safety data
No additional data of relevance.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Lactose
Maize Starch
Yellow Iron Oxide (E172)
Magnesium Stearate
Purified Water

6.2 Incompatibilities
None reported.

6.3  Shelf life
3 years.

6.4 Special precautions for storage
Do not store above 30°C.

6.5 Nature and contents of container
The tablets are supplied in securitainers containing 50 or 500 tablets or blister packs containing 30, 45, 60 or 100 tablets

6.6 Special precautions for disposal and other handling
For detailed instructions for use refer to the Patient Information Leaflet in every pack.

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

Chlorphenamine Maleate Tablets USP 1mg Taj Pharma

Package leaflet: Information for the patient

Chlorphenamine maleate Tablets USP 4mg Taj Pharma

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Chlorphenamine  is and what it is used for
2. Before you are given Chlorphenamine
3. How you will be given  Chlorphenamine
4. Possible side effects
5. How Chlorphenamine  is stored
6. Further Information

1. What Chlorphenamine is and what it is used for
Chlorphenamine is used to treat the allergic symptoms of hayfever and other allergies. The active ingredient is chlorphenamine maleate, an antihistamines which can help to relieve the symptoms of some allergies, rhinitis (runny and itchy nose) and itchy skin rashes, it can be used to treat the itchiness, redness, swelling, tenderness and irritation that can be caused by: .
· hayfever and other allergies e.g. pet , house, dust mite and mould spore allergies
· skin allergies and dermatitis
· nettle rash and urticaria (hives)
· prickly heat and heat rash
· reactions to foods, food additives or medicines
· insect bites and stings
· the itchy rash of chickenpox

2. Before you are given Chlorphenamine
Do not take Chlorphenamine if you
· are allergic to Chlorphenamine, any of the other ingredients in the tablets (listed in section 6 of this leaflet) or to other antihistamines
· are taking monoamine oxidase inhibitors (MAOIs) prescribed for depression or have taken them within the last 14 days

Warning and precautions
Talk to your doctor or pharmacist before taking this medicine if you
· have epilepsy
· have liver, kidney, or heart disease, severe high blood pressure
· have bronchitis, asthma or bronchiectasis
· have an enlarged prostate gland
· have glaucoma.

Chlorphenamine with alcohol Chlorphenamine may increase the effects of alcohol. Therefore DO NOT DRINK ALCOHOL whilst taking Chlorphenamine.

Other medicines and Chlorphenamine
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription. In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Chlorphenamine tablets work:
· Medicines to treat anxiety or to help you sleep
· Phenytoin (for epilepsy)
· If you are taking other medicines containing other antihistamines, including products for the relief of colds and coughs.

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Chlorphenamine.

Pregnancy and breast-feeding
If you are pregnant, planning a pregnancy or are breast-feeding, ask your doctor or pharmacist for advise before taking Chlorphenamine.

Driving and using machines
Chlorphenamine may cause drowsiness, dizziness, blurred vision or lack of co-ordination. Do not drive or operate machinery if you are affected in this way and do not drink alcohol, as it can make these effects worse.

Chlorphenamine contains lactose
If you know you have an intolerance to lactose or other sugars tell your doctor or pharmacist before taking Chlorphenamine.

3. How you will be given Chlorphenamine
The tablets can be divided into equal doses.
Always take Chlorphenamine exactly as described in this leaflet or as your pharmacist or doctor has told you. If you are not sure how to take this medicine talk to your doctor or pharmacist.

Dosage
The recommended doses are given below:

Adults and children over 12 years of age
One tablet every 4-6 hours. Do not take more than 6 tablets in 24 hours.

Children aged 6 – 12 years
Half a tablet every 4-6 hours. Do not give more than 6 half tablets in 24 hours.
Elderly:
Talk to your doctor or pharmacist before you take this medicine as you may be more likely to get side effects including confusion and you may need to take a lower daily dose.
· Do not give to children under 6 years
· Do not take more than the recommended dose.

If you take more Chlorphenamine than you should
Contact your doctor or go to a hospital immediately. Show them the package or container. Do not drive if you have taken too many tablets. If you forget to take Chlorphenamine Take one as soon as you remember, unless it is nearly time to take your next scheduled dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Chlorphenamine
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If your symptoms persist, see your doctor.

4. Possible Side Effects
Like all medicines, Chlorphenamine can cause side effects, although not everybody gets them.

Additional side effects in children
Children and the elderly are likely to be more sensitive to the effects of Chlorphenamine.

The most common side effect is drowsiness. This drowsiness can be helpful if symptoms are particularly troublesome at night.

STOP TAKING this medicine and tell your doctor or go to a hospital immediately if you:
· Experience a severe allergic reaction swelling of the face, lips, mouth or throat leading to difficulty in breathing or swallowing; raised and itchy skin
· Experience liver problems.
· Experience anaemia or unexplained bleeding or bruising.
· Experience difficulty passing urine.
· Collapse.

The following side effects may occur:
· headache
· dry mouth
· diarrhoea
· Indigestion
· loss of appetite
· aches and pains in the stomach area
· weakness, weariness
· difficulty concentrating
· blurred vision
· fast or irregular heart beat
· low blood pressure
· serious allergic reaction, which may cause difficulty in breathing or dizziness
· skin rash, redness, itching or hives
· sensitivity to sunlight
· dizziness
· tightness of the chest
· thickening of phlegm
· lack of co-ordination
· muscle weakness, twitching
· ringing in the ears
· irritability
· nightmares
· over-excitement in children
· confusion
· nausea
· vomiting
· depression

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. By reporting side effects you can help provide more information on the safety of this medicine

5. How Chlorphenamine is stored
Keep out of the reach and sight of children.
Store below 25°C and protect from light.
Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container.
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. Further information

What Chlorphenamine  contains
The active ingredient in Chlorphenamine tablets is chlorphenamine maleate.
Each tablet contains: Chlorphenamine Maleate USP            4mg
The other ingredients are lactose, maize starch, povidone, magnesium stearate, sodium starch glycollate and quinoline yellow (E104).

What Chlorphenamine  looks like and contents of the pack
Chlorphenamine tablets are round pale yellow tablets.
The tablets come in containers of 100, 500 and 1000 tablets and in blister packs of 10, 28, 30 and 60 tablets.
Not all pack sizes 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

Chlorphenamine Maleate Tablets USP 1mg Taj Pharma

Package leaflet: Information for the patient

Chlorphenamine maleate Tablets USP 4mg Taj Pharma

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Chlorphenamine  is and what it is used for
2. Before you are given Chlorphenamine
3. How you will be given  Chlorphenamine
4. Possible side effects
5. How Chlorphenamine  is stored
6. Further Information

1. What Chlorphenamine is and what it is used for
Chlorphenamine is used to treat the allergic symptoms of hayfever and other allergies. The active ingredient is chlorphenamine maleate, an antihistamines which can help to relieve the symptoms of some allergies, rhinitis (runny and itchy nose) and itchy skin rashes, it can be used to treat the itchiness, redness, swelling, tenderness and irritation that can be caused by: .
· hayfever and other allergies e.g. pet , house, dust mite and mould spore allergies
· skin allergies and dermatitis
· nettle rash and urticaria (hives)
· prickly heat and heat rash
· reactions to foods, food additives or medicines
· insect bites and stings
· the itchy rash of chickenpox

2. Before you are given Chlorphenamine
Do not take Chlorphenamine if you
· are allergic to Chlorphenamine, any of the other ingredients in the tablets (listed in section 6 of this leaflet) or to other antihistamines
· are taking monoamine oxidase inhibitors (MAOIs) prescribed for depression or have taken them within the last 14 days

Warning and precautions
Talk to your doctor or pharmacist before taking this medicine if you
· have epilepsy
· have liver, kidney, or heart disease, severe high blood pressure
· have bronchitis, asthma or bronchiectasis
· have an enlarged prostate gland
· have glaucoma.

Chlorphenamine with alcohol Chlorphenamine may increase the effects of alcohol. Therefore DO NOT DRINK ALCOHOL whilst taking Chlorphenamine.

Other medicines and Chlorphenamine
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription. In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Chlorphenamine tablets work:
· Medicines to treat anxiety or to help you sleep
· Phenytoin (for epilepsy)
· If you are taking other medicines containing other antihistamines, including products for the relief of colds and coughs.

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Chlorphenamine.

Pregnancy and breast-feeding
If you are pregnant, planning a pregnancy or are breast-feeding, ask your doctor or pharmacist for advise before taking Chlorphenamine.

Driving and using machines
Chlorphenamine may cause drowsiness, dizziness, blurred vision or lack of co-ordination. Do not drive or operate machinery if you are affected in this way and do not drink alcohol, as it can make these effects worse.

Chlorphenamine contains lactose
If you know you have an intolerance to lactose or other sugars tell your doctor or pharmacist before taking Chlorphenamine.

3. How you will be given Chlorphenamine
The tablets can be divided into equal doses.
Always take Chlorphenamine exactly as described in this leaflet or as your pharmacist or doctor has told you. If you are not sure how to take this medicine talk to your doctor or pharmacist.

Dosage
The recommended doses are given below:

Adults and children over 12 years of age
One tablet every 4-6 hours. Do not take more than 6 tablets in 24 hours.

Children aged 6 – 12 years
Half a tablet every 4-6 hours. Do not give more than 6 half tablets in 24 hours.
Elderly:
Talk to your doctor or pharmacist before you take this medicine as you may be more likely to get side effects including confusion and you may need to take a lower daily dose.
· Do not give to children under 6 years
· Do not take more than the recommended dose.

If you take more Chlorphenamine than you should
Contact your doctor or go to a hospital immediately. Show them the package or container. Do not drive if you have taken too many tablets. If you forget to take Chlorphenamine Take one as soon as you remember, unless it is nearly time to take your next scheduled dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Chlorphenamine
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If your symptoms persist, see your doctor.

4. Possible Side Effects
Like all medicines, Chlorphenamine can cause side effects, although not everybody gets them.

Additional side effects in children
Children and the elderly are likely to be more sensitive to the effects of Chlorphenamine.

The most common side effect is drowsiness. This drowsiness can be helpful if symptoms are particularly troublesome at night.

STOP TAKING this medicine and tell your doctor or go to a hospital immediately if you:
· Experience a severe allergic reaction swelling of the face, lips, mouth or throat leading to difficulty in breathing or swallowing; raised and itchy skin
· Experience liver problems.
· Experience anaemia or unexplained bleeding or bruising.
· Experience difficulty passing urine.
· Collapse.

The following side effects may occur:
· headache
· dry mouth
· diarrhoea
· Indigestion
· loss of appetite
· aches and pains in the stomach area
· weakness, weariness
· difficulty concentrating
· blurred vision
· fast or irregular heart beat
· low blood pressure
· serious allergic reaction, which may cause difficulty in breathing or dizziness
· skin rash, redness, itching or hives
· sensitivity to sunlight
· dizziness
· tightness of the chest
· thickening of phlegm
· lack of co-ordination
· muscle weakness, twitching
· ringing in the ears
· irritability
· nightmares
· over-excitement in children
· confusion
· nausea
· vomiting
· depression

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. By reporting side effects you can help provide more information on the safety of this medicine

5. How Chlorphenamine is stored
Keep out of the reach and sight of children.
Store below 25°C and protect from light.
Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container.
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. Further information

What Chlorphenamine  contains
The active ingredient in Chlorphenamine tablets is chlorphenamine maleate.
Each tablet contains: Chlorphenamine Maleate USP            4mg
The other ingredients are lactose, maize starch, povidone, magnesium stearate, sodium starch glycollate and quinoline yellow (E104).

What Chlorphenamine  looks like and contents of the pack
Chlorphenamine tablets are round pale yellow tablets.
The tablets come in containers of 100, 500 and 1000 tablets and in blister packs of 10, 28, 30 and 60 tablets.
Not all pack sizes 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