Promethazine Hydrochloride Tablets USP 25mg Taj Pharma

1. Name of the medicinal product

Promethazine Hydrochloride Tablets USP 12.5mg Taj Pharma
Promethazine Hydrochloride Tablets USP 25mg Taj Pharma
Promethazine Hydrochloride Tablets USP 50mg Taj Pharma

2. Qualitative and quantitative composition

a) Each film coated tablet contains:
Promethazine Hydrochloride USP                  12.5mg
Excipients                                                         q.s.
Colours: Brilliant Blue FCF & Titanium Dioxide BP

b) Each film coated tablet contains:
Promethazine Hydrochloride USP                  25mg
Excipients                                                         q.s.
Colours: Brilliant Blue FCF & Titanium Dioxide BP

c) Each film coated tablet contains:
Promethazine Hydrochloride USP                  50mg
Excipients                                                         q.s.
Colours: Brilliant Blue FCF & Titanium Dioxide BP

For full list of excipients, see section 6.1

3. Pharmaceutical form

Tablet

4. Clinical particulars

4.1 Therapeutic indications

As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.

As an antiemetic.

For short term use:

Treatment of insomnia in adults.

For short term use as a paediatric sedative.

4.2 Posology and method of administration

Route of administration: Oral.

Not for use in children under the age of 2 years (see section 4.3).

As an antihistamine in allergy:

*Single doses are best taken at night.

As an antiemetic:

As a paediatric sedative for short term use and for short term treatment of insomnia in adults:

4.3 Contraindications

Promethazine should not be used in patients in coma or suffering from CNS depression of any cause.

Promethazine should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients.

Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression..

Promethazine should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.

4.4 Special warnings and precautions for use

Promethazine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.

Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency.

Caution should be exercised in patients with bladder neck or pyloro-duodenal obstruction.

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s Syndrome.

Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.

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

Promethazine should not be used for longer than 7 days without seeking medical advice.

4.5 Interaction with other medicinal products and other forms of interaction

Promethazine will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic. Alcohol should be avoided during treatment. Promethazine may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results. Promethazine should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results.

4.6 Fertility, pregnancy and lactation

Promethazine should not be used in pregnancy unless the physician considers it essential. The use of Promethazine is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonatal irritability and excitement.

4.7 Effects on ability to drive and use machines

Because the duration of action may be up to 12 hours, patients should be advised that if they feel drowsy they should not drive or operate heavy machinery.

4.8 Undesirable effects

The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 00 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).

Side effects may be seen in a few patients: drowsiness, dizziness, restlessness, headaches, nightmares, tiredness, and disorientation. Anticholinergic side effects such as blurred vision, dry mouth and urinary retention occur occasionally. Infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability. The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine. Other side-effects include urticaria, rash, pruritus, anorexia, gastric irritation, palpitations, hypotension, arrhythmias, extrapyramidal effects, muscle spasms and tic-like movements of the head and face. Anaphylaxis, jaundice and blood dyscrasias including haemolytic anaemia rarely occur. Photosensitive skin reactions have been reported. Strong sunlight should be avoided during treatment.

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 of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used.

Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines for systemic use; Phenothiazine derivatives.

Potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic properties.

5.2 Pharmacokinetic properties

Promethazine is distributed widely in the body. It enters the brain and crosses the placenta. Promethazine is slowly excreted via urine and bile. Phenothiazines pass into the milk at low concentrations.

5.3 Preclinical safety data

No additional preclinical data of relevance to the prescriber.

6. Pharmaceutical particulars

6.1 List of excipients

Lactose monohydrate, Maize starch, Povidone, Magnesium stearate, Polyethylene glycol, Hypromellose.

Titanium dioxide, Hypromellose, Indigo carmine aluminium lake FD&C.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 30°C. Store in the original carton in order to protect from light.

6.5 Nature and contents of container

Opaque white PVC/Aluminium blister Packing.

Packs Available: 7, 14, 28, 30, 50, 98, 100 and 500 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

7. Manufactured By:
Taj Pharmaceuticals Ltd. (Mumbai, India)
Unit No. 214, Old Bake House,
Maharashtra Chambers of commerce Lane,Fort,
Mumbai-400001 at: Ahmedabad- Gujarat, INDIA.

Promethazine Hydrochloride Tablets USP 12.5mg Taj Pharma
Promethazine Hydrochloride Tablets USP 25mg Taj Pharma
Promethazine Hydrochloride Tablets USP 50mg 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.

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet:

1. What Promethazine Tablets are and what they are used for
   2. What you need to know before you take Promethazine Tablets
   3. How to take Promethazine Tablets
   4. Possible side effects
   5. How to store Promethazine Tablets
   6. Contents of the pack and other Information
2. What Promethazine Tablets are and what they are used for

Promethazine Tablets contain a medicine called promethazine hydrochloride.

This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed.

What Promethazine Tablets are used for

Promethazine Tablets are used to treat the following conditions:

• For short term use: to treat adults with difficulty sleeping (insomnia)
• To treat allergic conditions such as hay fever or rashes (like nettle rash or hives)
• To treat or stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness
• For short term use: as a sedative for children aged 5 years and above

2. What you need to know before you take Promethazine Tablets

Do not take this medicine if:

• The person taking the medicine is under 5 years of age
• You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Promethazine Tablets (listed in Section 6 below). The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Promethazine Tablets if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure ask your doctor or pharmacist (see “Taking other medicines” section below)
• The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Promethazine Tablets.

Warnings and precautions

Check with your doctor or pharmacist before taking your medicine if

• You have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis)
• You have epilepsy
• You have any serious heart problems
• You have liver or kidney problems
• You have a stomach blockage or difficulty passing water
• You have hearing problems
• You have increased pressure in the eye (narrow angle glaucoma)
• You have had something called Reye’s Syndrome or possible Reye’s Syndrome – signs include being sick and confused following a viral illness

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Promethazine Tablets.

Other medicines and Promethazine Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Promethazine Tablets can affect the way some medicines work. Also some medicines can affect the way Promethazine Tablets work.

Do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks:

• Some medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are not sure ask your doctor or pharmacist

Tell your doctor or pharmacist if you are taking any of the following:

• Anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or weak bladder. These can increase the risk of dizziness, dry mouth and blurred eyesight
• Medicines for depression (such as amitriptyline)
• Medicines to help you to sleep or feel more relaxed (such as diazepam or zolpidem)
• Medicines such as aspirin (for arthritis and pain in your joints). Promethazine Tablets may hide the side effects of these medicines

Promethazine Tablets with food and drink

Do not drink alcohol while you are taking Promethazine Tablets. This is because it can affect the way the medicine works.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Promethazine Tablets should not be taken 2 weeks before birth.

You should not take Promethazine Tablets if you are breast-feeding. This is because small amounts may pass into mothers’ milk. This can be harmful to your baby.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel drowsy or sleepy after taking this medicine or the morning after taking this medicine. If this happens, do not drive or use any tools or machines.

Promethazine Tablets contains lactose:

• This is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine

3. How to take Promethazine Tablets

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The amount you need to take depends on the reason you are taking Promethazine Tablets. The following information will help you to decide how much you need to take.

Taking this medicine

• Take this medicine by mouth
• Do not take for longer than 7 days.
  If your symptoms worsen or do not improve after 7 days talk to your doctor or pharmacist
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

The recommended dose is:

For allergies (such as hay fever, rashes and hives)

Children 2-5 years:

• Promethazine Elixir should be given in this age group

Children 5-10 years:

• A single tablet (25mg) given at night
• DO NOT give more than 25mg each day

Children over 10 years and adults (including the elderly):

• Start with one tablet (25mg) taken at night
• This may be increased to a maximum of one tablet (25mg) twice a day if necessary

For treatment and prevention of feeling sick or being sick (such as travel sickness)

Children 2-5 years:

• Promethazine Elixir should be given in this age group

Children 5-10 years:

• Promethazine Elixir or Promethazine 10mg Tablets should be given in this age group

Children over 10 years and adults (including the elderly):

• A single tablet (25 mg) to be taken the night before the journey
• This may be repeated after 6-8 hours if necessary

As a short term paediatric sedative and for short term treatment of insomnia in adults

Children 2-5 years:

• Promethazine Elixir should be given in this age group

Children 5-10 years:

• A single tablet (25mg) given at night

Children over 10 years and adults (including the elderly):

• One or two tablets (25mg-50mg) taken at night

Use this medicine only as recommended. Do not exceed the recommended dose.

Exposure to sunlight

Promethazine Tablets can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine.

If you take more Promethazine Tablets than you should

If you or your child takes more Promethazine Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you or your child has taken.

The following effects may happen:

In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hallucinations, fits (seizures), loss of consciousness, uneven heart beat and breathing difficulties.

In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven heart beat and breathing difficulties.

If you forget to take Promethazine Tablets

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

• If you are taking Promethazine Tablets for an allergic condition – take your medicine as soon as you remember, then carry on as before
• If you are taking Promethazine Tablets for sedation or sleeping problems – miss that dose and take the next evening’s dose as usual

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

Tests

Taking Promethazine Tablets may affect the results of certain tests. These include some pregnancy tests and skin tests. Promethazine Tablets should not be taken at least 3 days before the start of a skin test.

4. Possible side effects

Like all medicines, Promethazine Tablets can cause side effects, although not everybody gets them.

Stop taking Promethazine Tablets and see a doctor or go to a hospital straight away if you notice any of the following side effects:

• An allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• Liver problems that may cause the eyes or skin to go yellow (jaundice)
• Muscle stiffness or shaking
• Being unable to control some muscles in your head or face
• You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling
• Very fast, uneven or forceful heartbeat (palpitations)
• Irregular heartbeat
• Tiredness which lasts for a long time. This may be due to a blood problem called anaemia
• Over-active behaviour in children

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.

• Dry mouth, blurred vision or you cannot pass water (urine)
• Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless
• Loss of appetite (anorexia), indigestion
• Feeling dizzy, lightheaded, faint (hypotension)
• Feeling confused, especially in elderly people
• Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps

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 Promethazine Tablets

• Keep this medicine out of the sight and reach of children
• Do not take Promethazine Tablets after the expiry date which is stated on the carton and blister pack after EXP. The expiry date refers to the last day of that month
• Store below 30°C
• Store in the original carton in order to protect from light

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. Contents of the pack and other Information

What Promethazine Tablets contains.

• Each tablet contains 12.5mg or 25mg or 50mg of the active substance, promethazine hydrochloride
• The other ingredients are lactose, maize starch, povidone, magnesium stearate, polyethylene glycol, Titanium dioxide, Hypromellose and Indigo carmine aluminium lake blue and hypromellose.

Opaque white PVC/Aluminium blister Packing.

Packs Available: 7, 14, 28, 30, 50, 98, 100 and 500 tablets.

Not all pack sizes may be marketed.

7. Manufactured By:
Taj Pharmaceuticals Ltd. (Mumbai, India)
Unit No. 214, Old Bake House,
Maharashtra Chambers of commerce Lane,Fort,
Mumbai-400001 at: Ahmedabad- Gujarat, INDIA.