Diphenhydramine hydrochloride Tablets USP 25mg Taj Pharma

1.NAME OF THE MEDICINAL PRODUCT
Diphenhydramine hydrochloride Tablets USP 25mg Taj Pharma.

2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablets contains:
Diphenhydramine Hydrochloride USP       25mg
Excipients                                                      q.s.

3.PHARMACEUTICAL FORM
Tablets to be taken orally.

4.CLINICAL PARTICULARS

4.1 Therapeutic indications
An aid to the relief of temporary sleep disturbance.

4.2  Posology and method of administration
Oral administration only.

Two tablets to be taken 20 minutes before going to bed, or as directed by a physician.

Do not exceed the stated dose or frequency of dosing.

Do not use in children under 16 years.

This medication should not be used continuously for more than 2 weeks without consulting a doctor.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Diphenhydramine is contraindicated in those with the following conditions: stenosing peptic ulcer, pyloroduodenal obstruction.

4.4 Special Warnings and precautions for use
Diphenhydramine should be used with caution in patients with myasthenia gravis, epilepsy or seizure disorders, narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis and chronic obstructive pulmonary disease (COPD), moderate to severe hepatic impairment and moderate to severe renal impairment.

Tolerance may develop with continuous use. Seek medical advice if sleeplessness persists, as insomnia may be a symptom of serious underlying medical illness.

This medication should not be used continuously for more than 2 weeks without consulting a doctor.

May increase the effects of alcohol, therefore alcohol should be avoided.

Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines.

Use with caution in the elderly, who are more likely to experience adverse effects. Avoid use in elderly patients with confusion.

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

Keep out of the sight and reach of children.

4.5 Interaction with other medicinal products and other forms of interaction
Diphenhydramine may potentiate the sedative effects of alcohol and other CNS depressants (e.g. tranquillizers, hypnotics and anxiolytics).

Monoamine oxidase inhibitors(MAOI) prolong and intensify the anticholinergic effects of diphenhydramine. The product should be used with caution with MAOIs or within 2 weeks of stopping an MAOI.

As diphenhydramine has some antimuscarinic activity, the effects of some anticholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated therefore medical advice should be sought before taking diphenhydramine with such medicines.

Diphenhydramine is an inhibitor of the cytochrome p450 isoenzyme CYP2D6. Therefore, there may be a potential for interaction with drugs which are primarily metabolised by CYP2D6, such as metoprolol and venlafaxine.

Diphenhydramine should not be used in patients receiving any of the above drugs unless directed by a doctor.

4.6 Fertility, Pregnancy and lactation
Pregnancy
Diphenhydramine crosses the placenta. Because animal reproduction studies are not always predictive of human response and since there is inadequate experience with use of diphenhydramine in pregnant women, the potential risk for humans is unknown. Use of sedating antihistamines during the third trimester may result in reactions in the newborn or premature neonates. This drug is not recommended during pregnancy. Consult a doctor before use.

Lactation
Diphenhydramine has been detected in breast milk, but the effect of this on breastfed infants is unknown. Diphenhydramine is not recommended for use during lactation. Consult a doctor before use.

4.7 Effects on ability to drive and use machines
Diphenhydramine is a hypnotic and will produce drowsiness or sedation soon after the dose has been taken. It may also cause dizziness, blurred vision, cognitive and psychomotor impairment. These can seriously affect the patient’s ability to drive and use machines. If affected, do not drive or operate 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 trials and which are considered to be common (occurring in > 1/100 to < 1/10) or very common (occurring in > 1/10) are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post- marketing use is unknown, but these reactions are likely to be uncommon (occurring in > 1/1,000 to <1/100) or rare (occurring in < 1/1,000).

* The elderly are more prone to confusion and paradoxical excitation.

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
Overdose is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include mydriasis, fever, flushing, agitation, tremor, dystonic reactions, hallucinations and ECG changes. Large overdose may cause rhabdomyolysis, convulsions, delirium, toxic psychosis, arrhythmias, coma and cardiovascular collapse.

Treatment should be supportive and directed towards specific symptoms. Convulsions and marked CNS stimulation should be treated with parenteral diazepam.

5. Pharmacological Properties

5.1 Pharmacodynamic properties
Diphenhydramine is an ethanolamine-derivative antihistamine. It is an antihistamine with anticholinergic and marked sedative effects. It acts by inhibiting the effects on H1-receptors.

Diphenhydramine is effective in reducing sleep onset (ie, time to fall asleep) and increasing the depth and quality of sleep.

5.2 Pharmacokinetic properties
Absorption
Diphenhydramine hydrochloride is rapidly absorbed following oral administration. Apparently it undergoes first-pass metabolism in the liver and only about 40-60% of an oral dose reaches systematic circulation as unchanged Diphenhydramine.

Distribution
It is rapidly distributed throughout the whole body. Peak plasma concentrations are attained within 1-4 hours. The sedative effect also appears to be maximal within 1-3 hours after administration of a single dose.

It is positively correlated with the plasma drug concentration.

Biotransformation
Diphenhydramine is approx 80-85% bound to plasma proteins. Diphenhydramine is rapidly and almost completely metabolised. The drug is metabolised principally to Diphenylmetoxyacetic acid and is also dealkylated.

The metabolites are conjugated with glycine and glutamine and excreted in urine. Only about 1% of a single dose is excreted unchanged in urine.

Elimination
The elimination half-life ranges from 2.4-9.3 hours in healthy adults. The terminal elimination half-life is prolonged in liver cirrhosis.

5.3 Preclinical safety data
None stated.

6. Pharmaceutical Particulars

6.1 List of excipients
Anhydrous lactose
Stearic acid, powder
Microcrystalline cellulose
Silicon dioxide
Maize starch

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
Diphenhydramine has a shelf-life of 4 years in HDPE bottles and 3 years in blister packs.

6.4 Special precautions for storage
Store in a dry place.

6.5 Nature and contents of container
High density polyethylene bottles with a polypropylene closure and cotton wool wadding, or an aclar/polyethylene/PVC or PVC/PVDC strip with a heat sealable aluminium foil. Bottles of 16 or 20 tablets and strips of 4, 8, 16, 20 or 24 tablets.

6.6 Special precautions for disposal and other handling
Not applicable.

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

Diphenhydramine hydrochloride Tablets USP 25mg Taj Pharma

Package leaflet: Information for the patient

Diphenhydramine hydrochloride Tablets USP 25mg 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  Diphenhydramine Hydrochloride is and what it is used for
2. Before you are given Diphenhydramine Hydrochloride
3. How you will be given  Diphenhydramine Hydrochloride
4. Possible side effects
5. How Diphenhydramine Hydrochloride is stored
6. Further Information

1. What Diphenhydramine Hydrochloride is and what it is used for
   This medicine contains the active substance diphenhydramine hydrochloride which is an antihistamine with sedative properties which induces drowsiness or sedation. It works by reducing the time needed to fall asleep and increases the depth and quality of sleep. This medicine is used to aid relief of temporary sleep disturbance (difficulties sleeping) in adults and children over 16 years of age.
2. Before you are given Diphenhydramine Hydrochloride
   Do not take this medicine:
   • if you are allergic to diphenhydramine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
   • if you have a peptic ulcer
   • if you have a blockage between your stomach and small intestine.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
• if you suffer from myasthenia gravis (abnormal muscle function)
• if you suffer from seizures or have epilepsy
• if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD)
• if you have narrow angle glaucoma
• if you have enlarged prostate
• if you have difficulty urinating
• if you have moderate to severe liver or kidney problems
• if you are elderly, particularly if you also suffer from confusion.

This medicine is for short term sleeping problems. It may not work as well if you use it continuously. If your problems with sleeping persist, see your doctor for advice.

Other medicines and Diphenhydramine Hydrochloride Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following:
• other antihistamines including those used on your skin and in cough and cold medicines
• tranquillisers or anxiolytics (sedatives) used to treat anxiety e.g. diazepam
• hypnotics (e.g. nitrazepam) used to help you sleep better
• monoamine oxidase inhibitors (MAOIs) for depression (e.g. phenelzine) or if you have stopped taking an MAOI within the last two weeks
• metoprolol (a beta blocker) used to treat high blood pressure, angina, irregular heart beat or overactive thyroid
• venlafaxine used to treat depression
• antimuscarinics which relax smooth muscles and are used for example in Parkinsons Disease, irritable bowel syndrome and incontinence e.g. procyclidine, trihexyphenidyl, atropine, oxybutinin, fesoterodine
• tricyclic antidepressants (e.g. imipramine, amitriptyline).

Diphenhydramine Hydrochloride Tablets with alcohol
Do not drink alcohol if you are taking this medicine.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
This medicine causes drowsiness and sedation and may also cause dizziness, blurred vision, disturbance in attention and slower reaction times. Do not drive or operate machinery while you are affected in this way.

Diphenhydramine Hydrochloride Tablets contain lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How you will be given Diphenhydramine Hydrochloride
   Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

The recommended dose is
Adults and children over 16 years:
Take two tablets 20 minutes before going to bed.
Do not exceed the stated dose.

Use in children:
Do not use in children under 16 years of age.
This medicine is for oral use. Swallow the tablets whole with water.

If you take more tablets than you should
If you take too much of this medicine it is likely to result in effects similar to those listed below in section 4. Possible Side Effects. Other effects may include dilated pupils, fever, flushing, agitation, shaking, movement disorder, seeing or hearing things that are not real or ECG changes. A large overdose may cause abnormal muscle breakdown which can lead to kidney problems, fits, delirium, loss of contact with reality, irregular heartbeat, coma or cardiovascular collapse.
Talk to your doctor or pharmacist if you take too many tablets. Take the medicine pack with you.

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

4. Possible Side Effects
   Like all medicines, this medicine can cause side effects, although not everybody gets them.
   If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact you doctor, as these may be signs of an allergic reaction:
   • difficulty breathing or shortness of breath, swelling of the face, mouth or throat
   • rash, hives (itchy, raised red weals).

If you notice any of the following effects tell your doctor straightaway:
• fever, chills, sore throat, infections. These may be signs of a blood disorder
• faster heartbeat, irregular heartbeat
• fits, difficulty making or controlling movements.

Tell your doctor, pharmacist or nurse if you suffer from any of the following other effects:

Common effects (may affect up to 1 in 10 people):
• sedation, drowsiness, dizziness, unsteadiness, disturbance in attention
• dry mouth
• fatigue.

Other effects:
• palpitations (feeling your heartbeat)
• headache, tingling or numbness (pins and needles)
• depression, sleep disturbances
• confusion, excitation e.g. increased energy, restlessness, nervousness (the elderly are more likely to experience these effects)
• difficulty urinating or inability to pass urine
• thicker bronchial mucus
• blurred vision
• feeling or being sick, stomach problems
• muscle twitching.

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 Diphenhydramine Hydrochloride is stored
   Keep this medicine out of the sight and reach of children.
   Do not use this medicine after the expiry date which is stated on the label, carton or blister after “EXP”. The expiry date refers to the last day of that month.
   Keep this medicine in the pack provided and protect from light and moisture.
   Do not use this medicine if you notice any change in the appearance of the tablets.
   Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Further information

What Diphenhydramine Hydrochloride contains
The active substance is diphenhydramine hydrochloride.
Each tablet contains: Diphenhydramine hydrochloride USP        25mg

The other ingredients are lactose, maize starch, pregelatinised maize starch and magnesium stearate.

What Diphenhydramine Hydrochloride looks like and contents of the pack
The tablets are white, round tablets and are available in pack sizes of 16 and 20 tablets (Not all 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