1 mg/ml solution
What Tavegyl is and what it is used for
Tavegyl contains the active substance clemastine, which belongs to the drug group antihistamines and is used to relieve allergy symptoms.
Tavegyl blocks the effects of histamine, a substance released in the body in many types of allergic reactions.
Tavegyl is used for:
- to treat various allergic conditions such as hives, hay fever, insect bites, and Quincke’s edema (short-term appearance of allergic swelling). Tavegyl has a general antipruritic effect and is used for various types of itching, especially for various skin rashes.
- to prevent allergic reactions when using contrast media (given before x-ray examination).
What you need to know before using Tavegyl
Do not use Tavegyl
- if you are allergic to clemastine or any of the other ingredients of this medicine (listed in section 6)
- for children under 1 year of age.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tavegyl if you have any of the following conditions:
- glaucoma (increased pressure in the eye)
- serious illness of the stomach or intestines
- prostate enlargement
- a disease that obstructs the bladder
- myasthenia gravis (muscle disease)
- porphyria (metabolic disease)
Tavegyl may cause dry mouth in some patients. Good oral hygiene is important during long-term treatment because a dry mouth can increase the risk of caries. Problems for contact lens wearers may arise due to decreased tear flow.
Children and young people
Tavegyl should not be given to children under 1 year of age.
Other medicines and Tavegyl
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tavegyl enhances the sedative effect of sleeping pills, anti-depressant drugs ( monoamine oxidase inhibitors (MAOIs), antidepressants), anti-anxiety and sedative drugs, and anti-pain drugs ( opioids ).
Tavegyl with food, drink, and alcohol
Avoid alcohol when you are treated with Tavegyl, as the ability to react is further impaired when alcohol is consumed at the same time.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
No adverse effects on the fetus have been demonstrated, but no studies have been done on pregnant women. Clemastine passes into breast milk. Therefore, the use of Tavegyl during pregnancy and breastfeeding should only take place after a doctor’s prescription.
Driving ability and use of machinery
Like many other antihistamines, Tavegyl can impair the ability to react in some patients. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tavegyl contains sorbitol and ethanol
Tavegyl contains sorbitol and patients with the following rare hereditary conditions should not take this medicine: fructose intolerance.
Tavegyl contains 70 mg of ethanol per ml, which is harmful in case of alcoholism and should be considered when treating children and high-risk groups such as patients with liver disease and epilepsy.
How to use Tavegyl
Tavegyl will be given to you as an injection by your doctor who will decide which
the dose that is right for you.
Adults
The normal dose is 1 ampoule (2mg/2ml) which is given as an injection into a muscle or vein.
Older
The lowest possible dose should be chosen when treating the elderly.
Mode of administration
Injection of Tavegyl into the vein must be carried out very slowly (injection time 2-3 minutes. Alternatively, before injection, the content of the ampoule can be diluted with physiological saline or 5% glucose solution in a ratio of 1:5 (a 2 ml ampoule is diluted with an 8 ml solution).
Tavegyl must not be injected into your artery.
S on preventive treatment when using X-ray contrast agents:
2 ml (2 mg) which is injected into a vein about 3 minutes before the injection of contrast liquid.
Use for children and adolescents
Tavegyl should not be given to children under 1 year of age.
If you have used too much Tavegyl
It is unlikely that you will receive the wrong dose as Tavegyl should always be given under the supervision of a healthcare professional. If you are worried that you have received the wrong dose or have any questions, talk to your doctor, nurse, or pharmacist.
If you forget to use Tavegyl
As Tavegyl solution for injection will be given as an injection by healthcare professionals, it is unlikely that any dose will be forgotten. If you still think you have missed a dose, contact your doctor. Do not take a double dose to make up for a missed dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Tavegyl and seek medical help immediately if you experience any of the following symptoms:
- difficulty breathing or swallowing
- swelling of the face, lips, tongue, or throat
- severe itching of the skin with red rashes or raised nodules
- severe drop in blood pressure
These may be signs of hypersensitivity reaction, and anaphylactic shock which has been reported as rare side effects (may affect up to 1 in 1,000 users).
Common side effects (may affect up to 1 in 10 users):
- fatigue, drowsiness
Uncommon side effects (may affect up to 1 in 100 users):
- dizziness, hypersensitivity reaction, and shortness of breath.
Rare side effects (may affect up to 1 in 1,000 users):
- excited state (especially in children), dry mouth, headache, skin rash and stomach pain, nausea.
Very rare side effects (may affect up to 1 in 10,000 users):
- tachycardia (palpitations) and constipation.
How Tavegyl should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the ampoule one after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is clemastine. 1 ml solution for injection contains: 1.340 mg clemastine fumarate corresponding to 1 mg clemastine.
Other excipients are ethanol (96% v/v), propylene glycol, sodium citrate, sorbitol (E 420), and water for injections.
Appearance and package sizes of the medicine
Liquid for injection, solution, in glass ampoule for intravenous or intramuscular injection.
Clear, colorless to the very pale yellow or pale greenish-yellow solution.
Carton with 5×2 ml, glass ampoules.
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare A/S
Nykær 68
2605 Brøndby, Denmark
Phone: 020-100579.
Manufacturer:
GlaxoSmithKline Consumer Healthcare A/S, Nykær 68, 2605 Brøndby, Denmark.