LORATADINE 10MG TABLETS
Active substance: LORATADINE
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PAGE 1: FRONT FACE (INSIDE OF REEL)
PAGE 2: REAR FACE (OUTSIDE OF REEL)
you start taking this medicine if you: have severe liver problems (see section 3, How to take Loratadine). ALLERGY RELIEF 10 mg TABLETS Other precautions you should take This product may prevent a response to LORATADINE allergens in skin allergy testing; therefore you should stop taking this medicine at PACKAGE LEAFLET: least 2 days before any such testing. INFORMATION FOR THE USER Pregnancy and breast-feeding Read all of this leaflet carefully because it Do not take Loratadine if you are pregnant or breast-feeding. contains important information for you. Ask your doctor or pharmacist for advice This medicine is available without before taking any medicine. prescription. However you still need to take Loratadine carefully to get the best Driving and using machines: results from it. Loratadine may make you feel Keep this leaflet. You may need to drowsy. Do not drive or operate any read it again. tools or machines if affected. Ask your pharmacist if you need Important information about some of more information or advice. the ingredients of Loratadine You must contact a doctor if your Patients who are intolerant to lactose symptoms worsen or do not improve. should note that Loratadine tablets If any of the side effects get serious, contain a small amount of lactose. If you or if you notice any side effects not have been told by your doctor that you listed in this leaflet, please tell your have an intolerance to some sugars, doctor or pharmacist. contact your doctor before taking this medicinal product. IN THIS LEAFLET: 1. What Loratadine is and what it is used 3 HOW TO TAKE LORATADINE for 2. Before you take Loratadine If your doctor has prescribed this 3. How to take Loratadine medicine, always take Loratadine exactly 4. Possible side effects as your doctor has told you. Otherwise 5. How to store Loratadine follow the instructions below. You should 6. Further information check with your doctor or pharmacist if you are not sure. The tablets should be swallowed, 1 WHAT LORATADINE IS AND WHAT IT IS USED FOR preferably with a drink of water. The usual dose is: Loratadine belongs to a group of Adults and Children over 12 years of age drugs called antihistamines which One 10 mg tablet once daily. help to relieve the symptoms of some Children aged 2 - 12 years of age are allergies. dosed by weight: Your medicine is used to relieve Bodyweight more than 30kg: 10mg once symptoms such as sneezing, runny daily (one tablet once daily). nose and burning, itchy eyes due to Loratadine tablets are not suitable for hayfever and other allergies. children with a body weight of less than 30 Loratadine tablets can also be taken kg. to relieve symptoms due to skin allergies such as rash, itching or Children under 2 years of age urticaria (hives). Loratadine is not recommended for children under 2 years of age. 2 BEFORE YOU TAKE LORATADINE Patients with severe liver problems Adults and Children over 2 years of age: Do NOT take Loratadine if you: Bodyweight more than 30kg: 10mg (one are allergic (hypersensitive) to tablet) every other day. loratadine or any of the other If you take more Loratadine than you ingredients of this medicine. should If you (or someone else) swallow a lot of Take special care with Loratadine Talk to your doctor or pharmacist before the tablets all together, or if you think a
child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Overdose may cause sleepiness, fast heart rate and headache. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. If you forget to take Loratadine If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
feeling sick (nausea), dry mouth, inflammation of the stomach, which may lead to stomach pain, being sick, or loss of appetite (gastritis) abnormal liver function (shown by blood test results) rash, hair loss (alopecia) tiredness (fatigue) If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5
HOW TO STORE LORATADINE
4
POSSIBLE SIDE EFFECTS
Like all medicines, Loratadine can cause side effects, although not everybody gets them. If the following happens, stop taking Loratadine and tell your doctor immediately or go to the casualty department at your nearest hospital: a severe allergic reaction (swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing). This is a very serious but very rare side effect. You may need urgent medical attention or hospitalisation. The following side effects have been reported at the approximate frequencies shown: Children aged 2 to 12 years: Common (affects less than 1 in 10 patients receiving the medicine): headache nervousness tiredness (fatigue). Adults and children over 12 years: Common (affects less than 1 in 10 patients receiving the medicine): drowsiness (somnolence). Uncommon (affects less than 1 in 100 patients receiving the medicine): headache increased appetite difficulty sleeping (insomnia). Very rare (affects less than 1 in 10,000 patients receiving the medicine): dizziness fast or uneven heartbeat (tachycardia, palpitations)
Keep out of the reach and sight of children. There are no special storage conditions. Do not transfer the tablets to another container. Do not use Loratadine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that 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
What Loratadine tablets contain: The active ingredient is loratadine 10 mg. The other ingredients are lactose, maize starch, pregelatinised starch and magnesium stearate. What Loratadine tablets look like and contents of the pack: White, oval tablets, scored on one side and plain on the other, debossed L and 10 on each side of the scoreline. The product is available in packs of 5, 7, 10, 14, 15, 20, 28, 30, 50, and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: March 2012
PL 00289/0371
86844-U V4 19-03-12
PAGE 2: REAR FACE (OUTSIDE OF REEL)
you start taking this medicine if you: have severe liver problems (see section 3, How to take Loratadine). ALLERGY RELIEF 10 mg TABLETS Other precautions you should take This product may prevent a response to LORATADINE allergens in skin allergy testing; therefore you should stop taking this medicine at PACKAGE LEAFLET: least 2 days before any such testing. INFORMATION FOR THE USER Pregnancy and breast-feeding Read all of this leaflet carefully because it Do not take Loratadine if you are pregnant or breast-feeding. contains important information for you. Ask your doctor or pharmacist for advice This medicine is available without before taking any medicine. prescription. However you still need to take Loratadine carefully to get the best Driving and using machines: results from it. Loratadine may make you feel Keep this leaflet. You may need to drowsy. Do not drive or operate any read it again. tools or machines if affected. Ask your pharmacist if you need Important information about some of more information or advice. the ingredients of Loratadine You must contact a doctor if your Patients who are intolerant to lactose symptoms worsen or do not improve. should note that Loratadine tablets If any of the side effects get serious, contain a small amount of lactose. If you or if you notice any side effects not have been told by your doctor that you listed in this leaflet, please tell your have an intolerance to some sugars, doctor or pharmacist. contact your doctor before taking this medicinal product. IN THIS LEAFLET: 1. What Loratadine is and what it is used 3 HOW TO TAKE LORATADINE for 2. Before you take Loratadine If your doctor has prescribed this 3. How to take Loratadine medicine, always take Loratadine exactly 4. Possible side effects as your doctor has told you. Otherwise 5. How to store Loratadine follow the instructions below. You should 6. Further information check with your doctor or pharmacist if you are not sure. The tablets should be swallowed, 1 WHAT LORATADINE IS AND WHAT IT IS USED FOR preferably with a drink of water. The usual dose is: Loratadine belongs to a group of Adults and Children over 12 years of age drugs called antihistamines which One 10 mg tablet once daily. help to relieve the symptoms of some Children aged 2 - 12 years of age are allergies. dosed by weight: Your medicine is used to relieve Bodyweight more than 30kg: 10mg once symptoms such as sneezing, runny daily (one tablet once daily). nose and burning, itchy eyes due to Loratadine tablets are not suitable for hayfever and other allergies. children with a body weight of less than 30 Loratadine tablets can also be taken kg. to relieve symptoms due to skin allergies such as rash, itching or Children under 2 years of age urticaria (hives). Loratadine is not recommended for children under 2 years of age. 2 BEFORE YOU TAKE LORATADINE Patients with severe liver problems Adults and Children over 2 years of age: Do NOT take Loratadine if you: Bodyweight more than 30kg: 10mg (one are allergic (hypersensitive) to tablet) every other day. loratadine or any of the other If you take more Loratadine than you ingredients of this medicine. should If you (or someone else) swallow a lot of Take special care with Loratadine Talk to your doctor or pharmacist before the tablets all together, or if you think a
child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Overdose may cause sleepiness, fast heart rate and headache. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. If you forget to take Loratadine If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
feeling sick (nausea), dry mouth, inflammation of the stomach, which may lead to stomach pain, being sick, or loss of appetite (gastritis) abnormal liver function (shown by blood test results) rash, hair loss (alopecia) tiredness (fatigue) If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5
HOW TO STORE LORATADINE
4
POSSIBLE SIDE EFFECTS
Like all medicines, Loratadine can cause side effects, although not everybody gets them. If the following happens, stop taking Loratadine and tell your doctor immediately or go to the casualty department at your nearest hospital: a severe allergic reaction (swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing). This is a very serious but very rare side effect. You may need urgent medical attention or hospitalisation. The following side effects have been reported at the approximate frequencies shown: Children aged 2 to 12 years: Common (affects less than 1 in 10 patients receiving the medicine): headache nervousness tiredness (fatigue). Adults and children over 12 years: Common (affects less than 1 in 10 patients receiving the medicine): drowsiness (somnolence). Uncommon (affects less than 1 in 100 patients receiving the medicine): headache increased appetite difficulty sleeping (insomnia). Very rare (affects less than 1 in 10,000 patients receiving the medicine): dizziness fast or uneven heartbeat (tachycardia, palpitations)
Keep out of the reach and sight of children. There are no special storage conditions. Do not transfer the tablets to another container. Do not use Loratadine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that 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
What Loratadine tablets contain: The active ingredient is loratadine 10 mg. The other ingredients are lactose, maize starch, pregelatinised starch and magnesium stearate. What Loratadine tablets look like and contents of the pack: White, oval tablets, scored on one side and plain on the other, debossed L and 10 on each side of the scoreline. The product is available in packs of 5, 7, 10, 14, 15, 20, 28, 30, 50, and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: March 2012
PL 00289/0371
86844-U V4 19-03-12
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
