TAVEGYL TBL 1MG N20

ATC code: R06AA04 

Active substances: Clemastinum

Vendor, principal: Novartis Consumer Health. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

TAVEGYL 1MG N20

Package leaflet: Information for the user

Tavegyl, 1 mg tablets

Clemastine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use 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 3 days.

What is in this leaflet

1.   What Tavegyl is and what it is used for
2.   What you need to know before you take Tavegyl
3.   How to take Tavegyl
4.   Possible side effects
5.   How to store Tavegyl
6.   Contents of the pack and other information

1.   What Tavegyl is and what it is used for

Tavegyl contains the active substance clemastine which is an antihistamine used for alleviating allergic reactions. Tavegyl blocks the effects of histamine, a substance released in the body during allergic reactions (symptoms can include red rash, tissue swelling or severe itching). Tavegyl tablets are used for symptomatic treatment of allergic rhinitis, for symptomatic treatment of urticaria, and for relieving itching allergic non-inflammatory skin conditions (dermatoses).
If you have any further questions about Tavegyl, ask your doctor or pharmacist.

2.   What you need to know before you use Tavegyl Do not take Tavegyl:

-   if you are allergic to clemastine, other antihistamines or any of the other ingredients of this medicine (listed in section 6)
-   if you have porphyria (metabolic disorder)
Do not give Tavegyl to children below 3 years of age due to high active substance content.

Inform your doctor if any of the above conditions applies to you, because Tavegyl is not suitable for you in this case.

Warnings and precautions

If you have any of the following conditions:
-   glaucoma (increased pressure in the eye),
-   severe stomach problems,
-   prostate disorders,
-   bladder neck obstruction
Talk to your doctor or pharmacist if anything in the above list is applicable to you.

Other medicines and Tavegyl

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including over-the-counter medicines, especially the following: tranquillisers or antidepressants that you use for treating sleep disorders or depression or for calming.

Tavegyl with food and drink

Like many other antihistamines, Tavegyl may intensify the effects of alcohol. Avoid consuming alcohol whilst taking this medicine.

Pregnancy, breast-feeding and fertility

Do not take Tavegyl tablets during pregnancy and breast-feeding or when trying to conceive. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Like other antihistamines, Tavegyl can reduce attentiveness in some people. If you experience any side effects, do not drive or use machines.

Tavegyl tablets contain lactose

If you have been told by your doctor that you have intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Tavegyl

Always take 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. Take tablets before meals with water.
Adults and children 12 years and older:
1 tablet twice a day, in the morning and at night. Do not take more than 6 tablets per 24 hours if not prescribed otherwise by your doctor. Never take more than 2 tablets per dose.
Children from 3 to 12 years:
Give one tablet before breakfast and before bed.
Children from 3 to 6 years: 0.5 mg (V tablet);
Children from 6 to 12 years 0.5 - 1 mg (V - 1 tablet).
Do not exceed the recommended dose.

If you take more Tavegyl than you should

In case of over-dosage or accidental ingestion, contact your doctor, pharmacist or emergency medical service.

If you forget to take Tavegyl

Take a dose as soon as you remember to do so and continue using the medicine as usual. Do not take a double dose to make up for a forgotten dose.

4.   Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Discontinue using Tavegyl and seek medical attention if you have any of the following side effects, which can be symptoms of an allergic reaction:
-   breathing or swallowing difficulties
-   swelling of face, lips, tongue or throat
-   severe skin itching with red rash and pimples

Other side effects:

Treatment with Tavegyl can cause fatigue and drowsiness.

Uncommon side effects:

-   dizziness

Rare side effects:

-   excitability, especially in children, breathing problems, hypersensitivity reactions (incl. shock) (see the symptoms above), dry mouth, headache, skin rash, upset stomach.

Very rare side effects:

-   tachycardia (rapid heartbeat).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Tavegyl

Do not store above 30°C.
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 carton after EXP. The expiry date refers to the last day of that month.
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 Tavegyl contains

-   The active substance is clemastine. One tablet contains 1 mg of clemastine (as 1.34 mg of clemastine fumarate).
-   Excipients are: magnesium stearate, povidone, talc, maize starch, lactose monohydrate.

What Tavegyl looks like and contents of the pack

Whitish, round, flat uncoated tablets, 7 mm in diameter, with bevelled edges, marked with a break-line on one side and letters “OT” on the other. The tablet can be divided in two equal doses.
The pack includes 20 or 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

GlaxoSmithKline Consumer HealthCare (UK) Trading Ltd.
980 Great West Road, Brentford Middlesex, TW8 9GS United Kingdom

Manufacturer:

Novartis Consumer Health GmbH Zielstattstrasse 40 81379 Munich Germany.
GSK Consumer Healthcare GmbH & Co. KG Barthstraße 4 80339 Munich Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Eesti OÜ Phone: +372 6676 900 [email protected]

This leaflet was last revised in October 2016.

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