Paracetamol/Pseudoephedrine Hydrochloride 500mg/30mg Tablets
ID: S 179M (DCP) Version: 01 Review Date: 19/10/2016
PACKAGE LEAFLET: INFORMATION FOR THE USER Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
Paracetamol/Pseudoephedrine Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
The name of this medicine is Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
What is in this leaflet
1. What Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets are and what they are used for
2. What you need to know before you take Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
3. How to take Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
4. Possible side effects
5. How to store Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
6. Contents of the pack and other information
1. What Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets is and what it is used for_
Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets relieves the symptoms of colds and flu including aches, pains, fever, nasal and sinus congestion.
The tablets contain paracetamol, an analgesic and antipyretic to relieve pain and fever, and pseudoephedrine, a decongestant to clear nasal congestion and blocked sinuses.
This medicine is for use in adults and adolescents aged 15 years and over
2. What you need to know before you take Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets_
Do not take this medicine:
• If you are allergic to paracetamol or pseudoephedrine or any of the other ingredients of this medicine (listed in section 6).
• If you have high blood pressure or heart disease
• If you are taking any other paracetamol containing products
• If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs)
• If you are taking tricyclic antidepressants.
• If you have hyperthyroidism (an excessive secretion of thyroid hormones).
• If you have glaucoma (increased pressure in the eye). .
• If you have urinary retention (difficulty passing water).
• If you have pheochromocytoma which is a tumour of the adrenal glands (glands near
the kidneys) causing high blood pressure.
• If you are taking any other sympathomimetic drugs (stimulants or appetite suppressants and drugs to treat asthma and congestion).
• If you are taking beta blockers (medicines used to treat conditions such as angina, heart failure and high blood pressure).
• If you are taking the antibacterial agent furazolidine.
If any of these apply to you, get advice from a doctor or pharmacist without using Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets if you:
• have kidney or liver problems (including Gilbert’s Syndrome)
• have a deficiency of a certain enzyme called glucose-6-phosphatase
• have haemolytic anaemia (abnormal breakdown of red blood cells)
• in case of dehydration or chronic malnutrition
• weigh less than 50kg
• have diabetes
• have prostate problems (difficulty with passing water or needing to pass water often)
• have a long term cough, asthma or emphysema
• have alcohol dependence
• have occlusive vascular problems e.g. Raynaud’s Phenomenon
• have psychosis
If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist. Children and adolescents
Do not give to children and adolescents under 15 years old.
Other medicines and Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets if you are taking:
• Or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs)
• Tricyclic antidepressants (used to treat mood disorder)
• Other sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma)
• Beta blockers (used for example to treat high blood pressure)
• If you are taking any other paracetamol containing products
Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets and certain other medicines can affect each other and your doctor may need to adjust the doses that you are taking. It is especially important if you are taking any of the following medicines as well as Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
• Antihypertensives (drugs to treat high blood pressure such as guanethidine, methyldopa, alpha and beta blockers, debrisoquine, bretylium and betanidine)
• Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma)
• Cholestyramine (to lower blood cholesterol)
• Metoclopramide and domperidone (to treat nausea and vomiting)
• Anticoagulants (to thin the blood such as warfarin)
• Barbiturates (used to treat anxiety or help you sleep)
• Oral contraceptives ("the pill")
• Anticonvulsants (drugs used to treat epilepsy)
• Rifampicin and isoniazid (used to treat tuberculosis).
• Chloramphenicol (antibiotic drug) (not including topical chloramphenicol).
• Zidovudine (antiretroviral drug used to prevent and treat HIV/AIDS).
• Probencid (treatment for gout)
• Halogenated anaesthetics (such as halothane and cyclopropane)
• Cardiac glycosides (medicines used to treat heart failure and irregular heartbeats).
• Linezolide (antibiotic used for the treatment of serious infections.
If you are not sure about any of the medicines you are taking, show the pack to your pharmacist.
Pregnancy, breast-feeding and fertility
Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets is not recommended in 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.
Driving and using machines
There are no known effects on driving and using machines as a result of taking Paracetamol/Pseudoephedrine. If you are affected by dizziness while taking this medicine you are advised not to drive or operate machinery.
3. How to take Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Check the table that follows to see how much medicine to take.
|
Age |
Dose |
|
Adults and adolescents aged 15 years and over. |
1 to 2 tablets every 4 - 6 hours, two to three times a day |
• Leave at least 4 hours between doses.
• Do not take more than 3 doses in 24 hours.
• Patients should seek medical advice if symptoms persist for more than 3 days or worsen.
• For oral use only.
• Do not exceed stated dose.
• Take with a glass of water.
• The dose may require adjustment in patients with kidney or liver problems and in frail, elderly patients.
The effective daily dose should not exceed 2g/day of paracetamol in the following situations unless advised by a doctor:
• Weight less than 50kg
• Liver impairment
• Chronic alcoholism
• Dehydration
• Chronic malnutrition
If you take more Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets than you should
Immediate medical advice should be sought in the event of overdose because of the risk of irreversible liver damage.
If you forget to take Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets
If you forget to take a dose, take the next dose when needed provided that the last dose was taken at least 4 hours ago. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them, and they are usually mild.
If you experience any of the following, stop using this medicine and talk to your doctor:
• A few people have had hallucinations, but this is rare.
• Occasionally people get skin rashes that are sometimes itchy.
• A few men, especially those with prostate problems, may have trouble passing water.
• There have been rare reports of blood disorders in people taking paracetamol, the symptoms of which include unusual tiredness, unexpected bruising or bleeding and getting more infections (such as colds) than normal.
• Increased blood pressure and effects on the heart, such as a fast heartbeat.
Long-term use
• People who use medicine containing paracetamol every day for a long time (several months or more) could get certain side-effects including liver and kidney damage. People taking paracetamol in the usual way for shorter periods have not had these problems.
Other effects which may occur include:
• Restlessness, having trouble getting to sleep or bad dreams.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via UK Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5._How to store Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg _Tablets_
This medicine does not require any special storage conditions.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information_
What Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets contain
The active ingredients in Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets are: 500 mg Paracetamol and 30 mg Pseudoephedrine hydrochloride per tablet.
Other ingredients are: Pregelatinised maize starch, crospovidone, povidone K30, stearic acid, microcrystalline cellulose, sodium starch glycollate Type A, magnesium stearate.
What Paracetamol/Pseudoephedrine hydrochloride 500mg/30mg Tablets looks like and the contents of the pack
The tablets are white to off-white, capsule shaped tablets.
Paracetamol 500 mg / Pseudoephedrine HCl 30 mg Tablets are available in blister packs of 4, 10, 12, 15, 18, 20, 24, 30 and 32 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chanelle Medical Loughrea Co. Galway Ireland
Manufacturer
Chanelle Medical Loughrea Co. Galway Ireland
JSC Grindeks
53 Krustpils street, Riga, LV-1057 Latvija