10 mg orodispersible tablet

Read all of this leaflet carefully before you start using this medicine.

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

– Save this leaflet, you may need to read it again.

– Contact the pharmacy staff if you need more information or advice.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

– You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

In this leaflet you will find information about: 
1. What is Ebastin Apofri and what is it used for? 
2. Before you use Ebastin Apofri 
3. How to use Ebastin Apofri 
4. Possible side effects 
5. Storage of Ebastin Apofri
6. Other information

What does Ebastin Apofri contain?

The active substance is ebastine. 1 orodispersible tablet contains 10 mg of ebastine.

The other ingredients (excipients) are hypromellose (E464), povidone (E1201), poloxamer, gelatin, Carmello calcium, crospovidone, mannitol (E421), microcrystalline cellulose (E460), croscarmellose sodium (E468), silica (E468) natural silica (E468) flavors, gum arabic (E414), maltodextrin, sodium benzoate (E211) and butyl hydroxyanisole (E320), neotame (E961) and magnesium stearate (E470).

Marketing Authorisation Holder

Apofri AB

Box 120

182 12 Danderyd

Manufacturer

MEDREICH PLC

Warwick House

Plane Tree Crescent

Feltham, TW13 7 HF

UK

MEIJI PHARMA SPAIN SA

Avda de Madrid, 94

Alcala de Henares,

Madrid, 28802

Spain

1. WHAT IS EBASTIN APO-FREE AND WHAT IS IT USED FOR?

The appearance of the drug:

White to off-white, round orodispersible tablets with beveled edges and a diameter of approximately 8.5 mm and a thickness of 2.2 mm and marked “10” on one side.

Pharmaceutical group

Ebastin Apofri is an antihistamine, which counteracts the effect of histamine. Histamine is a substance in the body’s tissues that are triggered when you are exposed to allergenic substances and which, among other things, triggers runny nose, nasal congestion, and sneezing as well as eye problems such as red, watery and itchy eyes. Insensitive individuals, histamine can also cause troublesome itching and skin rashes after mosquito bites.

What is Ebastin Apofri used for?

Ebastin Apofri is used for temporary allergic symptoms such as red, watery, and itchy eyes as well as runny nose, nasal congestion, and sneezing. The allergic problems can be caused by, among other things, pollen, fur animals, mites, or dust. Ebastin Apofri can also be used by people who are sensitive to mosquito bites, during temporary stays in mosquito-rich areas.

Ebastin contained in Ebastin Apofri may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. BEFORE YOU USE EBASTIN APOFRI

Do not use Ebastin Apofri

  • if you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

  • Ebastin Apofri may cause dry mouth. For long-term treatment, good oral hygiene is therefore important (teeth should be cleaned with fluoride toothpaste twice daily) to prevent the risk of caries.
  • If you have a severe hepatic impairment, you should consult a doctor before starting treatment with Ebastin Apofri.

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is limited experience of use during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

It is unknown whether ebastine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Some people may react with drowsiness and dizziness to this type of medicine.

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/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ebastin Apofri contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.

Use of other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ebastin Apofri may affect or be affected by certain medicines that contain any of the following active substances:

  • ketoconazole , itraconazole ( antifungal drugs),
  • erythromycin ( antibiotics ),
  • rifampicin (a medicine used to treat tuberculosis ).

3. HOW TO USE EBASTIN APOFRI

Dosage instructions

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults and children over 12 years is 1 orodispersible tablet of 10 mg melted on the tongue once a day in connection with breakfast for a maximum of 14 days. For more severe allergic symptoms, the dose can be increased to 2 orodispersible tablets of 10 mg daily. Ebastin Apofri should not be given to children under 12 years of age.

Patients with severe hepatic impairment should not take more than 1 orodispersible tablet of 10 mg per day.

If you want to use Ebastin Apofri for longer than 14 days, you should contact a doctor to rule out a more serious cause of the problem.

The effect of Ebastin Apofri comes within 1 hour and lasts for 24 hours after taking the dose. Fur animal allergy sufferers should take Ebastin Apofri 1 hour before visiting a home with fur animals. In case of itching caused by mosquito bites, you get the best effect if Ebastin Apofri is taken before you have been bitten by a mosquito. People who are extra sensitive to mosquito bites have the greatest effect. The effect on itching lasts less than 2 hours and therefore does not affect the latter phase of itching after mosquito bites.

Administration

User manual:

Ebastin Apofri has a peelable foil. The symbol with an arrow, on the edge of the blister, shows the appropriate place to separate the foil from the underlying foil containing orodispersible tablets.

– Carefully pull off the back of an orodispersible tablet, as shown by the arrow

– Take the orodispersible tablet out of its pocket

The orodispersible tablet is then placed on the tongue, where it is immediately dissolved. Water or other liquid does not need to be used. The orodispersible tablets should be carefully removed from the blister with dry hands so that it is not crushed. The tablet should then be taken as soon as possible.

If you use more Ebastin Apofri than you should:

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Ebastin Apofri:

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.

Stop taking Ebastine Apofri and seek immediate emergency medical attention if you experience symptoms such as:

itching, itchy rash, difficulty swallowing, shortness of breath, low blood pressure, and swelling of the face, tongue, and throat. This may be a sign of a severe allergic reaction, which has been reported in rare cases.

The following side effects have also been reported:

Very common (may affect more than 1 user in 10):

  • headache

Common (may affect up to 1 in 10 people):

  • drowsiness
  • dry mouth

Rare (may affect up to 1 in 1,000 people):

  • nervousness
  • insomnia
  • dizziness
  • reduced feel
  • taste changes
  • palpitation
  • abnormal heart rhythm
  • abdominal pain
  • vomiting
  • nausea
  • digestive problems
  • liver effects
  • abnormal liver function tests
  • hives
  • rash
  • dermatitis
  • menstrual disorders
  • fluid retention ( edema )
  • fatigue

Has been reported (occurs in an unknown number of users):

  • weight gain
  • increased appetite

5. STORAGE OF EBASTIN APOFRI

Keep this medicine out of the sight and reach of children.

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. and on the blister after EXP. The expiration date is the last day of the specified 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

Pack sizes : 10, 15, 20 and 30 orodispersible tablets.

Not all pack sizes may be marketed.

Muhammad Nadeem

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