10 mg film-coated tablets
ebastine
1. What Ebastin Orifarm is and what it is used for
Ebastin Orifarm 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.
Ebastin Orifarm is used for temporary allergic conditions 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 Orifarm can also be used by people who are sensitive to mosquito bites, during temporary stays in mosquito-rich areas.
Ebastin contained in Ebastin Orifarm 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. What you need to know before using Ebastin Orifarm
Do not use Ebastin Orifarm
- if you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Ebastin Orifarm:
- if you have low levels of potassium in your blood
- if you have severe hepatic impairment.
Children and young people
Ebastin Orifarm should not be given to children under 12 years of age.
Other medicines and Ebastin Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Levels of ebastine (the active substance in Ebastine Orifarm) in the blood may increase if ebastine is taken with
- erythromycin (an antibiotic ) or
- ketoconazole (used to treat Cushing’s syndrome – when the body produces an excess of cortisol ) or
- itraconazole (a substance used to treat fungal infections).
Taking ketoconazole or erythromycin yourself may cause pronounced changes in the ECG.
Levels of ebastine (the active substance in Ebastine Orifarm) in the blood may be lowered, and the effect of ebastine may decrease if ebastine is taken with rifampicin (a substance used to treat tuberculosis ).
Pregnancy and breastfeeding
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.
Pregnancy
There is currently no experience with the safety of the unborn baby. For this reason, you should only take Ebastin Orifarm during pregnancy if your doctor thinks that the expected benefit outweighs the potential risks.
Breast-feeding
You should not take Ebastin Orifarm if you are breast-feeding, as it is not known if the active substance passes into breast milk.
Driving and using machines
Most patients treated with Ebastin Orifarm can drive and perform other activities that require good responsiveness. At recommended therapeutic doses, Ebastin Orifarm does not affect your ability to drive or use machines. As with any medicine, however, you should be aware of how you react after taking Ebastin Orifarm before driving or performing complicated activities. You may feel drowsy or dizzy. Also, read section 4. “Possible side effects”.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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.
How to use Ebastin Orifarm
Always take this medicine as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
The recommended dose is 1 tablet once daily for a maximum of 14 days. For more severe symptoms, the dose can be increased to 2 tablets daily. Ebastin Orifarm should not be given to children under 12 years of age.
Take Ebastin Orifarm 10 mg film-coated tablets with liquid without chewing. Ebastin Orifarm can be taken with or without food.
If you want to use Ebastin Orifarm for longer than 14 days, you should contact a doctor to rule out a more serious cause of the problem.
Impaired renal function
Patients with renal impairment may take the same dose as is normally recommended.
Hepatic impairment
Patients with mild or moderate hepatic impairment may take the same dose as is normally recommended.
In patients with severe hepatic impairment, the daily dose should not exceed 10 mg.
The tablet can be divided into two equal doses. Take the tablets with liquid without chewing them. The tablets can be taken with or without food.
If you take more Ebastin Orifarm then 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.
There is no special antidote for the active substance ebastine.
Depending on the severity of the situation, the physician will take appropriate measures (monitoring of vital bodily functions, including ECG monitoring with an evaluation of QT intervals for at least 24 hours, symptomatic treatment, and gastric lavage).
If you forget to take Ebastin Orifarm
Do not take a double dose to make up for a forgotten dose.
If you stop using Ebastin Orifarm
If you stop or stop treatment prematurely, you must expect the symptoms to return soon.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed:
Very common (may affect more than 1 user in 10):
- Headache
Common (may affect up to 1 in 10 people ):
- Somnolence
- Dry mouth
Rare (may affect up to 1 in 1,000 people):
- Allergic reaction (such as anaphylaxis (severe, life-threatening allergic reaction requiring immediate emergency medical attention) and swelling eg in the throat, lips, or hands ( angioedema ))
- General nervousness, insomnia
- Dizziness, decreased sensation, taste changes
- Palpitations, increased heart rate
- Abdominal pain, vomiting, nausea, indigestion
- Hepatic impairment elevated hepatic value in the blood ( transaminases, gamma-GT, alkaline phosphatases, and increased bilirubin )
- Hives, skin rash, dermatitis
- Menstrual disorders
- Edema (accumulation of fluid in the tissues ), fatigue
Has been reported (occurs in an unknown number of users):
- Weight gain
- Increased appetite
5. How to store Ebastin Orifarm
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/blister after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package in a light-sensitive manner.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is:
One film-coated tablet contains 10 mg of ebastine.
Other ingredients are
Tablet core:
Microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate.
Film coating:
Hypromellose, titanium dioxide, macrogol 400.
What the medicine looks like and the contents of the pack
Ebastin Orifarm 10 mg film-coated tablets are white to off-white, round film-coated tablets with beveled edges with a notch on one side and a diameter of 7.1 mm.
Alu-PVC / PVDC blister pack
10, 15, 20, and 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
This medicinal product is authorized under the European Economic Area under the names:
| Germany | Ebastin Lindopharm 10 mg film tablets |
| Belgium | Ebastine Teva 10 mg compressed pellets / film wrapped tablets / Film tablets |
| Finland | Kestox 10 mg calvopäällysteine tablets |
| Norway | Ebastin Orifarm 10 mg coated tablets |