Medication Guide App

TAVEGIL TABLETS

Active substance: CLEMASTINE HYDROGEN FUMARATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Recto

220 mm
70 mm

Pharma code XXX
11 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER

Clemastine hydrogen fumarate 1.34 mg

1. WHAT TAVEGIL TABLETS ARE AND WHAT THEY ARE USED FOR
Tavegil Tablets contain clemastine 1 mg as the active ingredient, which belongs to a group
of antihistamines. Tavegil 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.

2. BEFORE YOU TAKE TAVEGIL TABLETS
Do not take Tavegil Tablets if you have:
• an allergy (hypersensitivity) to any of the ingredients of Tavegil Tablets (see Section 6 and
Section 2 “Important information about some of the ingredients of Tavegil 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 Tavegil Tablets to children below one year of age.

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 Tavegil tablets may enhance the effects of drugs that :
• calm you (sedatives)
• induce sleep (hypnotics)
• treat depression (monoamine-oxidase inhibitors /MAOIs)
Taking Tavegil Tablets with food and drink
Like many other antihistamines, Tavegil Tablets may increase the effects of alcohol.
Do not consume alcohol whilst taking Tavegil Tablets.

150 mm

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

Take special care with Tavegil 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.
Antihistamines should be used with caution in children due to the risk of excitability in this
special population (see section 4)

Pregnancy and breast-feeding
Do not take Tavegil 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
Tavegil 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 Tavegil Tablets
Tavegil 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 TAVEGIL 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.

11 mm
11 mm

11 mm

Verso

220 mm
70 mm

Pharma code XXX
11 mm
XXXXXXX – IS-D1-A

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 Tavegil Tablets to children below one year of age.
If you use more Tavegil Tablets than you should
Taking too many Tavegil Tablets may cause either clinical depression or central nervous
system stimulation. Other symptoms such as dry mouth, fixed dilated pupils or flushing,
upset stomach and rapid heart beat may also develop.
If you accidentally take too many Tavegil 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 Tavegil 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.

Like all medicines, Tavegil Tablets can cause side effects, although not everybody gets them.
STOP taking Tavegil 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.

5. HOW TO STORE TAVEGIL TABLETS
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original pack.
Do not use Tavegil 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 pharmacist how to dispose of medicines no longer required. These measures will help to protect the
environment.

6. FURTHER INFORMATION
What Tavegil Tablets contain
The active substance of Tavegil is clemastine (as fumarate). Each tablet contains 1 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)
What Tavegil Tablets look like and contents of the pack
Tavegil Tablets are white, uncoated, round tablets, 7 mm in diameter with bevelled edges,
smooth on one side and marked with “OT” and scored with a single breakline on the other.
Tavegil tablets are available in:
• blister packs of 50 or 60 tablets.
Marketing Authorisation Holder and Manufacturer
Novartis Consumer Health UK Limited
Park View, Riverside Way
Watchmoor Park, Camberley
GU15 3YL, UK
For any information about this medicinal product, please contact the Marketing Authorisation Holder.
This leaflet was last revised June 2014.
Tavegil® is a registered Trade Mark.

150 mm

4. POSSIBLE SIDE EFFECTS

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

GB 308404

11 mm
11 mm

11 mm

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)