10 mg tablets
loratadine
What Loratadine ratiopharm is and what it is used for
Loratadine Ratiopharm is used for allergic conditions such as sneezing, runny nose, itchy nose, itching, and burning in the eyes.
Loratadine Ratiopharm is an antihistamine that does not cause fatigue and is used to treat certain allergic diseases. This drug works by blocking the effect of histamine which is involved and causes allergic reactions.
The allergic problems can be caused by e.g. pollen, fur animals, mites, or dust. Pollen allergy is seasonal to the pollen periods. Allergy to fur animals, mites, or dust can, on the other hand, occur all year round. This type of allergy can be treated temporarily if needed.
Common runny nose, so-called “cold runny nose” is caused by a virus and then antihistamines have no effect. Loratadine Ratiopharm should therefore not be used for colds other than allergic rhinitis.
Loratadine contained in Loratadine Ratiopharm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Loratadine ratiopharm
Do not use Loratadine ratiopharm:
- if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Loratadine Ratiopharm
- if you have severe liver disease.
Children
Loratadine Ratiopharm should not be given to children under 12 years of age without a doctor’s prescription.
This preparation must not be given to children under 2 years of age or children weighing less than 30 kg.
Other medicines and Loratadine ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are going to have a skin prick test, treatment with Loratadine Ratiopharm should be stopped at least 48 hours before so that the results are not affected.
Loratadine ratiopharm with alcohol
It is not necessary to avoid the use of alcohol during treatment with this medicine.
Pregnancy and breastfeeding
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 taking this medicine.
Do not use this medicine if you are pregnant, think you may be pregnant, or if you are breastfeeding your baby.
Driving and using machines
Treatment with Loratadine Ratiopharm may cause drowsiness or dizziness. If you feel affected, do not drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Loratadine ratiopharm contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Loratadine ratiopharm
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage for adults and children over 12 years with body weight over 30 kg: 1 tablet (10 mg) once daily.
Contact a doctor if the improvement is not seen after 7 days of treatment.
The duration of treatment may vary depending on your symptoms. Feel free to try to end the treatment if you think that the pollen season for you is over or if there are very low levels of pollen in the air. Use Loratadine Ratiopharm for a maximum of 3 consecutive months unless your doctor prescribes otherwise.
Loratadine Ratiopharm may cause dry mouth in some patients. Good oral hygiene (brushing teeth twice a day with fluoride toothpaste) is important in long-term treatment, as dry mouth can increase the risk of caries.
If you have severe liver disease, you may need to use a lower dose. Talk to your doctor or pharmacist before using this medicine.
Loratadine Ratiopharm should not be given to children under 12 years of age without a doctor’s prescription.
Do not exceed the stated dosage.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the following symptoms occur, stop using this medicine immediately and consult a doctor or go to the nearest health center or hospital: allergic reactions such as swelling of the lips, tongue, or face (Quincke’s edema ), difficulty breathing, and allergic reactions (low, burning, itchy marks on skin with swelling) or angioedema (swelling of the skin and mucous membranes). These are very serious side effects. If you get these symptoms, you may have had a severe allergic reaction. You may need immediate medication or hospitalization.
Common (may affect up to 1 in 100 people): Headache, nervousness, fatigue, sleep problems, increased appetite.
Very rare (may affect up to 1 in 10,000 people): dizziness, cramps, irregular or fast heartbeat, nausea, dry mouth, inflammation of the gastric mucosa ( gastritis, symptoms include abdominal pain, nausea, vomiting, diarrhea), abnormal liver function, rash, hair loss, fatigue.
Has been reported (occurs in an unknown number of users): weight gain
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.
How to store Loratadine ratiopharm
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. The expiration date is the last day of the specified month.
No special storage instructions.
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.
Contents of the pack and other information
Content declaration
- The active substance is loratadine . One tablet contains 10 mg of loratadine .
- The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch and magnesium stearate.
What the medicine looks like and contents of the pack
White, round, biconvex tablets with a scoreline on one side. The tablet can be divided into two equal parts.
This medicine is available in blister packs of 2, 7, 10, 14, 20, 20×1, 21, 28, 30, 50, 100 and 100×1 tablets. The medicine is supplied without a prescription in pack sizes of 10, 14, and 28.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany