1. Name of the medicinal product

Clemastine Fumarate Taj Pharma Tablets 1.34mg USP

  1. Qualitative and quantitative composition

Each uncoated tablet contains:
Clemastine                                   1mg
(as clemastine fumarate USP 1.34mg)

For excipients see 6.1

  1. Pharmaceutical form

Uncoated Tablets.

  1. Clinical particulars

4.1 Therapeutic indications

Allergic rhinitis, including hay fever and perennial rhinitis, vasomotor rhinitis.

Allergic dermatoses, including pruritus, atopic eczema and contact dermatitis.

Urticaria. Angioneurotic oedema, drug allergy.

4.2 Posology and method of administration

Adults

1mg clemastine base (one tablet) night and morning.

In individual cases the dose may be increased to 6mg clemastine base daily if necessary (six tablets).

Children

1 to 3 years: 250 microgrammes to 500 microgrammes clemastine base (¼ – ½ tablet night and morning.

3 to 6 years: 500 microgrammes clemastine base (½ tablet) night and morning.

6 to 12 years: 500 microgrammes to 1000 microgrammes clemastine base (½ – 1 tablet) night and morning.

Use in the elderly

No evidence exists that elderly patients require different dosages or show different side effects from younger patients.

Oral administration only.

Maximum duration of use: Clemastine fumarate should not be used for more than 14 days without consulting a doctor. Do not exceed the recommended dose

4.3 Contraindications

CLEMASTINE FUMARATE is contraindicated in patients with a known hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.

CLEMASTINE FUMARATE should not be given to porphyric patients.

CLEMASTINE FUMARATE should not be given to children below one year of age.

4.4 Special warnings and precautions for use

Antihistamines should be used with caution in patients with:

  • narrow-angle glaucoma
  • stenosing peptic ulcer
  • pyloroduodenal obstruction
  • prostatic hypertrophy with urinary retention and bladder neck obstruction.
  • children due to the risk of excitability in this special population (see section 4.8)
  • epilepsy or history of seizures
  • in the elderly, who are more likely to experience adverse effects such as paradoxical excitation. Avoid use in elderly patients with confusion. Do not exceed recommended dosage and duration of use without consulting a health care provider (See Dosage and Administration).

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

4.5 Interaction with other medicinal products and other forms of interaction

Antihistamines potentiate the sedative effects of Central Nervous System (CNS) depressants including hypnotics, monoamine-oxidase inhibitors (MAOI’s), antidepressants, anxiolytics, opioid analgesics and alcohol.

Patients should be advised to avoid alcoholic drinks.

As clemastine has some anticholinergic activity, the effects of some anticholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated.

4.6 Fertility, pregnancy and lactation

CLEMASTINE FUMARATE should not be given during pregnancy and breast-feeding.

4.7 Effects on ability to drive and use machines

TAVEGYL has moderate influence on the ability to drive and use machines, due to the antihistamine sedative effect of clemastine, however, patients should be warned not to take charge of vehicles or machinery until the effect of CLEMASTINE FUMARATE treatment on the individual is known.

4.8 Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000). or not known (can not to beestimated from available data). Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is not known but likely to be rare or very rare

MedDRA SOCAdverse ReactionFrequency
Immune system disordersAnaphylactic shockRare
Hypersensitivity reactionsRare
Psychiatric disordersExcitability, especially in childrenRare
Nervous system disordersSedationCommon
DizzinessUncommon
HeadacheRare
FatigueCommon
Cardiac disorderTachycardiaVery rare
PalpitationsVery rare
Respiratory, thoracic and mediastinal disordersDyspnoeaRare
Gastrointestinal disorderAbdominal painRare
NauseaRare
Dry mouthRare
ConstipationVery rare
Skin and subcutaneous tissue disordersSkin rashRare
General system disordersAstheniaRare

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: the effects of antihistamine overdose may vary from CNS depression to stimulation such as depressed level of consciousness, excitability, hallucinations, or convulsions. Anticholinergic symptoms such as dry mouth, mydriasis or flushing, gastrointestinal reactions and tachycardia may also develop.

Treatment: Treatment consists of symptomatic therapy or as recommended by the national poisons centres, where applicable.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines: H1-receptor.

Mechanism of action and pharmacodynamic effects

CLEMASTINE FUMARATE (clemastine) is an H1-recptor antagonist. It belongs to the benzhydryl ether group of antihistamines. CLEMASTINE FUMARATE inhibits selectively the histamine receptors of the H1 type and reduces capillary permeability. It exerts a potent antihistaminic and antipruritic effect with a fast onset and long duration of action up to 12 hours.

5.2 Pharmacokinetic properties

Absorption

Following oral administration CLEMASTINE FUMARATE (clemastine) is almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are attained within 2-4 hours. The antihistaminic activity of the drug reaches its peak after 5 to 7 hours; it usually persists for 10 to 12 hours, in some cases, however, for up to 24 hours.

Distribution

Plasma protein binding of clemastine amounts to 95%.

Biotransformation

Clemastine undergoes extensive metabolism in the liver.

Elimination

Elimination from plasma occurs biphasically, with half-lives of 3.6 ± 0.9 hours and 37 ± 16 hours. The major route of metabolite excretion (45 to 65%) is through the kidneys into urine, where only trace amounts of the parent compound are found. In lactating women, small amounts of the drug may pass into breast milk.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction at therapeutically relevant doses.

In a rat study, a reduction in pup survival, at doses more than 200X the therapeutic dose, was observed when mothers were treated through lactation.

  1. Pharmaceutical particulars

6.1 List of excipients

Lactose Monohydrate, Povidone, Maize Starch, Talc, Magnesium Stearate.

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions

6.5 Nature and contents of container

PVC/PVDC blister pack (30 tablets).

6.6 Special precautions for disposal and other handling

None.

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

 

Clemastine Fumarate Taj Pharma Tablets 1.34mg USP

Package leaflet: Information for the user

Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, you still need to use Clemastine Fumarate Tablets carefully to get the best results.

–– Keep this leaflet. You may need to read it again.

–– Ask your pharmacist if you need more information or advice.

–– You must contact a doctor if your symptoms worsen or do not improve.

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

In this leaflet:

  1. What Clemastine Fumarate Tablets are and what they are used for
  2. Before you use Clemastine Fumarate Tablets
  3. How to use Clemastine Fumarate Tablets
  4. Possible side effects
  5. How to store Clemastine Fumarate Tablets
  6. Further information

 

  1. WHAT CLEMASTINE FUMARATE TABLETS ARE AND WHAT THEY ARE USED FOR

Clemastine Fumarate Tablets contain clemastine 1 mg as the active ingredient, which belongs to a group of antihistamines. Clemastine Fumarate Tablets are used to treat:

  • allergic rhinitis (inflammation of the nasal mucous membranes) including hay fever, perennial rhinitis and vasomotor rhinitis.
  • allergic skin disease (dermatoses), including pruritus (intense itching), atopic eczema and contact dermatitis.
  • angioneurotic oedema (rapid swelling of the skin, mucosal tissues, internal organs or brain) and drug allergy.
  1. BEFORE YOU TAKE CLEMASTINE FUMARATE TABLETS

Do not take Clemastine Fumarate Tablets if you have:

  • an allergy (hypersensitivity) to any of the ingredients of Clemastine Fumarate Tablets (see Section 6 and Section 2 “Important information about some of the ingredients of Clemastine Fumarate Tablets”),
  • an allergy (hypersensitivity) to other arylalkylamine antihistamines (ask your doctor if you are unsure what these are)
  • Porphyria, a metabolism disorder which affects red blood cells and may cause blistering of the skin, abdominal pains and mental problems.

Do not give Clemastine Fumarate Tablets to children below one year of age.

Take special care with Clemastine Fumarate Tablets if you have:

  • narrow-angle glaucoma (a disease causing pressure behind the eye)
  • stenosing peptic ulcer (narrowing of the upper digestive tract caused by an ulcer)
  • pyloroduodenal obstruction (obstruction caused by inflammation of the intestine)
  • prostatic hypertrophy with urinary retention (enlargement of the prostate gland causing bladder control problems)
  • bladder neck obstruction
  • Epilepsy or history of seizures.

The elderly are more likely to experience adverse effects with this medicine. Carers should be aware that this medicine should not be given to elderly patients with confusion. Antihistamines should be used with caution in children due to the risk of excitability in this special population (see section 4)

Taking other medicines

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

Taking Clemastine Fumarate tablets may enhance the effects of drugs that :

  • calm you (sedatives)
  • induce sleep (hypnotics)
  • treat depression (monoamine-oxidase inhibitors /MAOIs)
  • make you drowsy or give dry mouth (anti-cholinergics)

Taking Clemastine Fumarate Tablets with food and drink

Like many other antihistamines, Clemastine Fumarate Tablets may increase the effects of alcohol.

Do not consume alcohol whilst taking Clemastine Fumarate Tablets.

Pregnancy and breast-feeding

Do not take Clemastine Fumarate Tablets if you are pregnant, intending to get pregnant, or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Clemastine Fumarate Tablets may cause drowsiness and fatigue. Do not drive or operate machinery if you are affected by the tablets in this way.

Important information about some of the ingredients of Clemastine Fumarate Tablets

Clemastine Fumarate 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.

  1. HOW TO TAKE CLEMASTINE FUMARATE TABLETS

Always take the medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and the Elderly

Take one tablet in the morning and one tablet at night with water.

In individual cases the dose may be increased to 6 tablets daily if necessary. Your doctor will

tell you if you need to increase the dose.

Do not exceed the recommended dose.

Children

  • 1 to 3 years: take ¼ – ½ tablet (250 mcg to 500 mcg) in the morning and at night.
  • 3 to 6 years: take ½ tablet (500 mcg) in the morning and at night.
  • 6 to 12 years: take ½ – 1 tablet (500 mcg to 1000 mcg) in the morning and at night.

Do not give Clemastine Fumarate Tablets to children below one year of age.

If you use more Clemastine Fumarate Tablets than you should

Taking too many Clemastine Fumarate Tablets may cause either clinical depression or central nervous system stimulation. Other sympto ms such as dry mouth, fixed dilated pupils or flushing, upset stomach and rapid heart beat may also develop.

If you accidentally take too many Clemastine Fumarate Tablets, or you suspect that your child has taken extra medicine, contact your doctor or hospital casualty department immediately. Take the carton and tablets with you if possible.

If you forget to take Clemastine Fumarate Tablets

Take a dose as soon as you remember then go on as normal, unless it is nearly time for your next dose.

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

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

  1. POSSIBLE SIDE EFFECTS

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

STOP taking Clemastine Fumarate and seek medical help immediately if you have any of the following which may be signs of an allergic reaction:

–– difficulty in breathing or swallowing

–– swelling of the face, lips, tongue or throat.

–– severe itching of the skin, with a red rash or raised bumps.

Common side effects (affecting 1 to 10 users in 100):

Fatigue and Drowsiness.

Uncommon side effects (affecting 1 to 10 users in 1, 000):

Dizziness

Rare side effects (affecting 1 to 10 users in 10, 000):

Headache, Excitability, upset stomach, nausea, dry mouth, skin rash, allergic reactions, shortness of breath and weakness

Very rare side effects (affecting 1 user in 10, 000):

Constipation, rapid heart beat, palpitations

In general, these side-effects may lessen if the dose is reduced.

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

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. You can also report side effects directly via

the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store.

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

  1. HOW TO STORE CLEMASTINE FUMARATE TABLETS

Keep out of the reach and sight of children.

This medicine does not require any special temperature storage conditions.

Do not use Clemastine Fumarate Tablets after the expiry ‘EXP’ date which is stated on the blister and the carton. The ‘EXP’ date refers to the last day of that month.

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

  1. FURTHER INFORMATION

What Clemastine Fumarate Tablets contain

The active substance of Clemastine Fumarate is clemastine (as as clemastine fumarate USP). Each tablet contains 1.34 mg of clemastine.

The other ingredients are: lactose, polyvinylpyrrolidone, maize starch, talc, magnesium stearate, purified water

(for further information about the ingredients see end of Section 2)

  • blister packs of 30 tablets.

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