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Flu Strength Hot Lemon Powder

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Document: leaflet MAH BRAND_PL 17907-0348 change

Package leaflet: Information for the user Flu Strength Hot Lemon Powder (Paracetamol 1000mg)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to take Flu Strength Hot Lemon Powder carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    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.

What is in this leaflet

1.    What Flu Strength Hot Lemon Powder is and what it is used for

2.    What you need to know before you take Flu Strength Hot Lemon Powder

3.    How to take Flu Strength Hot Lemon Powder

4.    Possible side effects

5.    How to store Flu Strength Hot Lemon Powder

6.    Contents of the pack and other information

1.    What Flu Strength Hot Lemon Powder is and what it is used for

Flu Strength Hot Lemon Powder is used for the relief of cold and flu symptoms such as headache, fever, aches and pain. It contains the active ingredient paracetamol which relieves pain and reduces body temperature when you have a fever.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days

2.    What you need to know before you take Flu Strength Hot Lemon Powder Do not take Flu Strength Hot Lemon Powder:

-    if you are allergic to allergic (hypersensitive) to paracetamol, other pain relievers or any of the other ingredients in the product (listed in section 6).

-    taking any other paracetamol-containing medicines

Warnings and precautions

Tell your doctor if you:

-    Are suffering from liver problems including liver problems due to excessive alcohol consumption

-    Gilbert’s syndrome (mild jaundice)

-    Are suffering from kidney problems

-    Are suffering from dehydration and chronic malnutrition

-    Suffer from asthma and are sensitive to aspirin

-    Are taking any other paracetamol containing medicines

-    Have a fever that does not improve after taking this medicine

-    Have glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency)

Have hemolytic anemia (abnormal breakdown of red blood cells). Are suffering from kidney or liver problems

Other medicines and Flu Strength Hot Lemon Powder

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those you have bought without a prescription.

Tell your doctor before you take Flu Strength Hot Lemon Powder if you are taking:

-    Drugs to thin the blood (anti-coagulant drugs e.g. Warfarin, other coumarins)

-    Medicines used to relieve sickness (e.g. Metoclopramide, Domperidone)

-    Medicines used to treat high cholesterol (Cholestyramine)

-    Probenecid (Medicine used to treat high levels of uric acid in the blood stream (gout))

-    Medicine to treat fever or mild pain (Aspirin, Salicylamide)

-    Barbiturates and tricyclic antidepressants (to treat depression)

-    Medicines used to treat epilepsy (Lamotrigine)

-    Medicines to treat tuberculosis (Isoniazid)

-    Other medicines containing paracetamol (see 'Do not take Flu Strength Hot Lemon Powder’)

-    Medication for your liver Effects of paracetamol on laboratory tests Uric acid and blood sugar tests may be affected.

Taking Flu Strength Hot Lemon Powder with food and drink

Avoid alcoholic drinks whilst taking this medicine.

This medicine may be taken with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant see your doctor before you take Flu Strength Hot Lemon Powder. Small amounts of paracetamol pass into breast milk. This medicine may be taken, as instructed (see section 3), by mothers who are breastfeeding.

Children and adolescents

This medicine is not recommended for children under 16 years of age.

Driving and using machines

Flu Strength Hot Lemon Powder is not expected to affect your ability to drive or operate machinery. Flu strength hot lemon powder contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains 9.37mmol (or 215.5mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Flu Strength Hot Lemon Powder

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For oral use only.

Adults and children 16 years and over The recommended dose is:

•    Dissolve the contents of one sachet in hot water and drink. Repeat every 4 hours.

•    The dose should not be repeated more frequently than 4 hourly intervals. You should not take

Flu Strength Hot Lemon Powder for longer than 3 days.

•    The maximum daily dose of Paracetamol must not exceed 4g (four sachets)

•    Maximum single dose is 1g (one sachet)

This medicine is not recommended for children under 16 years of age WARNING: DO NOT EXCEED THE STATED DOSE

Contains paracetamol. Do not take with other paracetamol containing products.

If symptoms persist consult your doctor. Do not use for more than 3 days without consulting your doctor.

If you take more Flu Strength Hot Lemon Powder than you should

It is extremely important to follow the dosage instructions that have been given to you. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain.

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

. Take any remaining medicine and this leaflet with you if possible. If you forget to take Flu Strength Hot Lemon Powder

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for the dose you have forgotten.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very rare cases of serious skin reactions have been reported.

•    accumulation of fluid in the larynx including an itchy rash, throat swelling (severe allergic

reaction),

•    swelling on the face, mouth, hands (angioedema)

You should stop taking Flu Strength Hot Lemon Powder and see your doctor immediately if you experience symptoms like:

•    Serious skin disease causing rash, skin peeling and sores.

•    Severe blistering and peeling of the skin.

The frequency using the following convention:

Rare (may affect up to 1 in 1,000 people):

Oedema (abnormal accumulation of fluid under the skin), abnormal vision, simple skin rash or urticaria (dark red rash on the skin), haemorrhage (bleeding), abdominal pain, diarrhoea, nausea, vomiting, dizziness, fever, reduction of irritability or agitation (sedation), platelet disorders (clotting disorders), stem cell disorders (disorders of the blood forming cell in the bone marrow), abnormal liver function, liver failure, hepatic necrosis (death of liver cells), jaundice, overdose and poisoning, tremor, headache, depression, confusion, hallucinations, sweating, pruritus (itching), feeling lousy (malaise).

Very rare (may affect up to 1 in 10,000 people):

Hepatotoxicity (damage caused to the liver), thrombocytopenia (reduction in blood platelets, which increases the risk of bleeding or bruising), leucopenia (frequent infections due to poorly functioning white blood cells or decrease in white blood cells), neutropenia (reduced neutrophil count in blood), agranulocytosis (severe decrease in white blood cells which may lead to severe infections), hemolytic anemia (abnormal breakdown of red blood cells, which may cause weakness or pale skin), hypoglycemia (low levels of glucose in the blood), cloudy urine and kidney disorders.

Other adverse reactions of paracetamol whose frequency cannot be estimated from available data are: anaemia (decrease in red blood cells), problems with the way your kidneys work (kidney alteration), problems with the way your liver works (liver alteration), haematuria (blood in urine), anuresis (inability to urinate), gastrointestinal effects, vertigo. There have been cases of difficulty breathing, wheezing, coughing, and shortness of breath with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs such as ibuprofen.

The following have also been reported:

•    blood abnormalities

•    drowsiness

•    Impaired mental function.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Flu Strength Hot Lemon Powder Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use Flu Strength Hot Lemon Powder after the expiry date shown on the pack. 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.


Contents of the pack and other information

What Flu Strength Hot Lemon Powder contains

The active substance is Paracetamol 1000mg.

The other ingredients are ascorbic acid, sucrose, sodium citrate, tartaric acid, citric acid, tapioca starch, sodium cyclamate, flav-o-lock lemon juice 610399, lemon flavour 8476, turmeric powder extract (curcumin E100). See also end of Section 2 on ‘Important information about some of the ingredients of Flu Strength Hot Lemon Powder’.

What Flu Strength Hot Lemon Powder looks like and contents of the pack

This medicine is a powder for oral solution. Each pack contains 5 or 10 sachets; each sachet contains 7.7g of powder.

Marketing Authorisation Holder

Bristol Laboratories Ltd,

Unit 3, Canalside,

Northbridge Road, Berkhamsted,

Herts, HP4 1EG, UK

Tel: 0044 (0)1442 200922

Fax: 0044 (0)1442873717

e-mail: info@bristol-labs.co.uk

Flu Strength Hot Lemon Powder; PL 17907/0348

This leaflet was last revised in October 2016

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address above (or telephone, fax, email)