UCERAX 10 MG/5 ML SYRUP
Active substance: HYDROXYZINE HYDROCHLORIDE
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G2-1353-26-B_MU3
Patient Information Leaflet
Ucerax
Syrup 10mg/5ml Hydroxyzine hydrochloride
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet Ucerax Syrup 10 mg/5 ml is called Ucerax Syrup. In this leaflet: 1. What Ucerax Syrup is for 2. Before you take Ucerax Syrup 3. How to take Ucerax Syrup 4. Possible side effects 5. How to store Ucerax Syrup 6. Further information.
1. What Ucerax Syrup is for
Ucerax Syrup belongs to a group of medicines called sedating antihistamines. It is thought to work by inhibiting some activity in the brain. Ucerax Syrup is used to treat: Anxiety in adults Itching (pruritus) caused by allergic reactions in adults and children. Do not take Ucerax Syrup if: You are allergic to hydroxyzine hydrochloride or any of the other ingredients of Ucerax Syrup (listed in Section 6) You are allergic to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine You are pregnant or breastfeeding You have a condition called porphyria. (A blood disease that can cause stomach pain, vomiting and mental disturbances such as depression.) If any of the above applies to you talk to your doctor or pharmacist. Check with your doctor or pharmacist before taking Ucerax Syrup if: You suffer from fits (convulsions)
You have an eye disease called glaucoma You have problems urinating You have kidney disease You have stomach problems You have dementia (a loss of mental abilities such as remembering) You have a condition called myasthenia gravis which weakens the muscles You have heart problems You have problems with your liver You have constipation You have a condition which means you have to be careful having sugar (such as diabetes or problems with your body digesting or absorbing sugar). This medicine contains 9.4 grams of sugar (sucrose) in every 12.5 ml dose. It may also be harmful to the teeth. This medicine contains small amounts of ethanol (alcohol) less than 100 mg per 25 ml dose. You are having allergy testing or a chest medical examination (asthma) in the next 5 days. Ucerax Syrup can affect the test results.
Taking Ucerax Syrup with food and drink Do not drink alcohol whilst you are taking Ucerax Syrup Pregnancy and breastfeeding Do not take Ucerax Syrup if you are pregnant, trying to become pregnant or breastfeeding. Driving and using machines Do not drive or operate machines if you take Ucerax Syrup. Ucerax Syrup may affect your ability to react and concentrate.
3. How to take Ucerax Syrup
Always take Ucerax Syrup exactly as your doctor has told you. Important: Your doctor will choose the dose that is right for you. Your dose and when to take it will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist. Adults For anxiety: The usual dose is 6.25 ml at breakfast, 6.25 ml at lunch and 12.5 ml in the evening Your doctor may increase this to a maximum of 150 ml a day taken in divided doses (for example, 50 ml three times a day). For pruritus (itchiness of the skin): The usual dose is 12.5 ml before going to bed Your doctor may increase this to 12.5 ml three or four times a day Do not take more than 100 ml of syrup at any one time. Do not take more than 150 ml of syrup in one day. Children For pruritus in children aged 6 years and over: The usual dose is 0.5 ml per kg of body weight a day, in divided doses. Your doctor may increase this to a maximum of 1 ml per kg of body weight a day, in divided doses. For pruritus in children from 1 year to 6 years: The usual dose is 0.5 ml per kg of body weight a day, in divided doses. Your doctor may increase this to a maximum of 1.25 ml per kg of body weight a day The elderly The usual starting dose is 6.25 ml before going to bed. Your doctor will tell you how much and when to take your syrup.
2. Before you take Ucerax Syrup
Tell your doctor if you are taking any of the following medicines: Betahistine used to treat Menieres disease (problems with balance and hearing) Phenytoin used for the treatment of fits (convulsions) Adrenaline used to treat severe allergic reactions. Ucerax Syrup may reduce the effect of these medicines. Also tell your doctor if you are taking: Medicines used to treat anxiety or help you sleep Anticholinergic medicines for the treatment of irritable bowel syndrome. Ucerax Syrup may increase the effect of these medicines. Tell your doctor if you are taking: Cimetidine used for the treatment of stomach problems. This may increase the level of Ucerax Syrup in your blood Monoamine oxidase inhibitors used for the treatment of depression Any other medicines including medicines obtained without a prescription.
People with liver and kidney problems Your doctor may choose a lower daily dose for you Your doctor will tell you how much syrup to take and when to take them. If you take more Ucerax Syrup than you should If you accidentally take too much, immediately go to the nearest hospital casualty department or your doctor. If you take more Ucerax Syrup than you should you may feel sick or be sick, feel sleepy, confused, or have heart palpitations, fever, unreactive pupils, the shakes, hallucinations, breathing problems, fits or low blood pressure. An overdose can lead to a coma and be fatal. If you forget to take Ucerax Syrup Do not take a double dose to make up for a missed dose. Simply take your next dose as planned. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Ucerax Syrup can cause side effects, although not everybody gets them. Stop taking Ucerax Syrup and seek immediate medical help if you have any of the following symptoms: An allergic reaction with difficulty in breathing, swelling or fever. A severe allergic reaction (also known as StevensJohnson syndrome) causing a fever, inflammation, blistering and ulceration of the skin which can result in the surface layer of the skin peeling away. Fits (convulsions). Your heart beat faster Your chest tightening and experience difficulty breathing. Your vision becomes blurred and you have difficulty focussing. An inability to pass water. Other side effects Very common side effects (affects more than 1 in 10 people): feeling sleepy Common side effects (affects less than 1 in 10 people) dry mouth, feeling tired, headache
Uncommon side effects (affects less than 1 in 100 people) dizziness, difficulty sleeping, unable to concentrate, weakness feeling sick, constipation Other side effects include: being sick, malaise (a feeling of discomfort or feeling unwell) involuntary limb movements, tremor disorientation, hallucination, confusion skin rashes (eruption of the skin), itching, hives, rash with blisters containing pus, pink/red blotchy rash which may form a ring, swelling of the skin particularly around the face abnormal liver function which may cause discomfort and tenderness in the upper abdomen, yellowing of the skin and whites of the eyes. low blood pressure increased sweating, fever If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In Ireland: UCB Pharma (Ireland) Limited, United Drug House, Magna Drive, Magna Business Park, City West Road, Dublin 24, Ireland Manufacturer: NextPharma SAS, 17 route de Meulan, F-78520 Limay, France. This leaflet was last updated in November 2010
5. How to store Ucerax Syrup
Keep out of the reach and sight of children. Keep the bottle in the outer carton. Do not use Ucerax Syrup after the expiry date on the bottle and carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist. What Ucerax Syrup contains The active substance in Ucerax Syrup is hydroxyzine hydrochloride. The syrup contains 10mg of hydroxyzine hydrochloride in each 5 ml. The other ingredients are sucrose, ethanol (alcohol), sodium benzoate (E211), menthol, imitation hazelnut flavour and purified water. What Ucerax Syrup looks like Each bottle contains 200 ml of hazelnut flavoured syrup. Marketing Authorisation Holder: In the UK: UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK
If this leaflet is difficult to see or read or you would like it in a different format, please contact: UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK
6. Further information
UCB (2010)
G2-1353-26-B_MU3
G2-1353-26-B_MU3
Patient Information Leaflet
Ucerax
Syrup 10mg/5ml Hydroxyzine hydrochloride
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet Ucerax Syrup 10 mg/5 ml is called Ucerax Syrup. In this leaflet: 1. What Ucerax Syrup is for 2. Before you take Ucerax Syrup 3. How to take Ucerax Syrup 4. Possible side effects 5. How to store Ucerax Syrup 6. Further information.
1. What Ucerax Syrup is for
Ucerax Syrup belongs to a group of medicines called sedating antihistamines. It is thought to work by inhibiting some activity in the brain. Ucerax Syrup is used to treat: Anxiety in adults Itching (pruritus) caused by allergic reactions in adults and children. Do not take Ucerax Syrup if: You are allergic to hydroxyzine hydrochloride or any of the other ingredients of Ucerax Syrup (listed in Section 6) You are allergic to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine You are pregnant or breastfeeding You have a condition called porphyria. (A blood disease that can cause stomach pain, vomiting and mental disturbances such as depression.) If any of the above applies to you talk to your doctor or pharmacist. Check with your doctor or pharmacist before taking Ucerax Syrup if: You suffer from fits (convulsions)
You have an eye disease called glaucoma You have problems urinating You have kidney disease You have stomach problems You have dementia (a loss of mental abilities such as remembering) You have a condition called myasthenia gravis which weakens the muscles You have heart problems You have problems with your liver You have constipation You have a condition which means you have to be careful having sugar (such as diabetes or problems with your body digesting or absorbing sugar). This medicine contains 9.4 grams of sugar (sucrose) in every 12.5 ml dose. It may also be harmful to the teeth. This medicine contains small amounts of ethanol (alcohol) less than 100 mg per 25 ml dose. You are having allergy testing or a chest medical examination (asthma) in the next 5 days. Ucerax Syrup can affect the test results.
Taking Ucerax Syrup with food and drink Do not drink alcohol whilst you are taking Ucerax Syrup Pregnancy and breastfeeding Do not take Ucerax Syrup if you are pregnant, trying to become pregnant or breastfeeding. Driving and using machines Do not drive or operate machines if you take Ucerax Syrup. Ucerax Syrup may affect your ability to react and concentrate.
3. How to take Ucerax Syrup
Always take Ucerax Syrup exactly as your doctor has told you. Important: Your doctor will choose the dose that is right for you. Your dose and when to take it will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist. Adults For anxiety: The usual dose is 6.25 ml at breakfast, 6.25 ml at lunch and 12.5 ml in the evening Your doctor may increase this to a maximum of 150 ml a day taken in divided doses (for example, 50 ml three times a day). For pruritus (itchiness of the skin): The usual dose is 12.5 ml before going to bed Your doctor may increase this to 12.5 ml three or four times a day Do not take more than 100 ml of syrup at any one time. Do not take more than 150 ml of syrup in one day. Children For pruritus in children aged 6 years and over: The usual dose is 0.5 ml per kg of body weight a day, in divided doses. Your doctor may increase this to a maximum of 1 ml per kg of body weight a day, in divided doses. For pruritus in children from 1 year to 6 years: The usual dose is 0.5 ml per kg of body weight a day, in divided doses. Your doctor may increase this to a maximum of 1.25 ml per kg of body weight a day The elderly The usual starting dose is 6.25 ml before going to bed. Your doctor will tell you how much and when to take your syrup.
2. Before you take Ucerax Syrup
Tell your doctor if you are taking any of the following medicines: Betahistine used to treat Menieres disease (problems with balance and hearing) Phenytoin used for the treatment of fits (convulsions) Adrenaline used to treat severe allergic reactions. Ucerax Syrup may reduce the effect of these medicines. Also tell your doctor if you are taking: Medicines used to treat anxiety or help you sleep Anticholinergic medicines for the treatment of irritable bowel syndrome. Ucerax Syrup may increase the effect of these medicines. Tell your doctor if you are taking: Cimetidine used for the treatment of stomach problems. This may increase the level of Ucerax Syrup in your blood Monoamine oxidase inhibitors used for the treatment of depression Any other medicines including medicines obtained without a prescription.
People with liver and kidney problems Your doctor may choose a lower daily dose for you Your doctor will tell you how much syrup to take and when to take them. If you take more Ucerax Syrup than you should If you accidentally take too much, immediately go to the nearest hospital casualty department or your doctor. If you take more Ucerax Syrup than you should you may feel sick or be sick, feel sleepy, confused, or have heart palpitations, fever, unreactive pupils, the shakes, hallucinations, breathing problems, fits or low blood pressure. An overdose can lead to a coma and be fatal. If you forget to take Ucerax Syrup Do not take a double dose to make up for a missed dose. Simply take your next dose as planned. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Ucerax Syrup can cause side effects, although not everybody gets them. Stop taking Ucerax Syrup and seek immediate medical help if you have any of the following symptoms: An allergic reaction with difficulty in breathing, swelling or fever. A severe allergic reaction (also known as StevensJohnson syndrome) causing a fever, inflammation, blistering and ulceration of the skin which can result in the surface layer of the skin peeling away. Fits (convulsions). Your heart beat faster Your chest tightening and experience difficulty breathing. Your vision becomes blurred and you have difficulty focussing. An inability to pass water. Other side effects Very common side effects (affects more than 1 in 10 people): feeling sleepy Common side effects (affects less than 1 in 10 people) dry mouth, feeling tired, headache
Uncommon side effects (affects less than 1 in 100 people) dizziness, difficulty sleeping, unable to concentrate, weakness feeling sick, constipation Other side effects include: being sick, malaise (a feeling of discomfort or feeling unwell) involuntary limb movements, tremor disorientation, hallucination, confusion skin rashes (eruption of the skin), itching, hives, rash with blisters containing pus, pink/red blotchy rash which may form a ring, swelling of the skin particularly around the face abnormal liver function which may cause discomfort and tenderness in the upper abdomen, yellowing of the skin and whites of the eyes. low blood pressure increased sweating, fever If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In Ireland: UCB Pharma (Ireland) Limited, United Drug House, Magna Drive, Magna Business Park, City West Road, Dublin 24, Ireland Manufacturer: NextPharma SAS, 17 route de Meulan, F-78520 Limay, France. This leaflet was last updated in November 2010
5. How to store Ucerax Syrup
Keep out of the reach and sight of children. Keep the bottle in the outer carton. Do not use Ucerax Syrup after the expiry date on the bottle and carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist. What Ucerax Syrup contains The active substance in Ucerax Syrup is hydroxyzine hydrochloride. The syrup contains 10mg of hydroxyzine hydrochloride in each 5 ml. The other ingredients are sucrose, ethanol (alcohol), sodium benzoate (E211), menthol, imitation hazelnut flavour and purified water. What Ucerax Syrup looks like Each bottle contains 200 ml of hazelnut flavoured syrup. Marketing Authorisation Holder: In the UK: UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK
If this leaflet is difficult to see or read or you would like it in a different format, please contact: UCB Pharma Limited, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK
6. Further information
UCB (2010)
G2-1353-26-B_MU3
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.
