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Ratiopharm Cold & Flu Lemon Flavour 500mg/12.2mg Powder For Oral Solution

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Package leaflet: Information for the patient

ratiopharm Cold & Flu Lemon Flavour 500mg/12.2mg Powder for Oral Solution (Paracetamol/Phenylephrine Hydrochloride)

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

-    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    only.

Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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. This includes any possible side effects not listed in this leaflet.

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 ratiopharm Cold & Flu Lemon Flavour is and what it is used for

2.    What you need to know before you take ratiopharm Cold & Flu Lemon Flavour

3.    How to take ratiopharm Cold & Flu Lemon Flavour

4.    Possible side effects

5.    How to store ratiopharm Cold & Flu Lemon Flavour

6.    Contents of the pack and other information

1. What ratiopharm Cold & Flu Lemon Flavour is and what ist is used for

ratiopharm Cold & Flu Lemon Flavour contains paracetamol, an analgesic which relieves aches and reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose.

ratiopharm Cold & Flu Lemon Flavour is used for the relief of the symptoms of colds and influenza, including the relief of aches , headache, nasal congestion and lowering of temperature.

Use ratiopharm Cold & Flu Lemon Flavour only if you have colds and flu accompanied by stuffy nose. If you do not have stuffy nose, monocomponent products containing only paracetamol should be preferred.

2. What you need to know before you take ratiopharm Cold & Flu Lemon Flavour Do not take ratiopharm Cold & Flu Lemon Flavour:

-    if you are allergic to paracetamol and phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

-    if you have severe coronary heart disease (a condition associated with impaired function of the heart)

-    if you have high blood pressure

-    if you have glaucoma (a disorder of the eyes often associated with increased pressure of the fluid in the eye)

-    if your thyroid gland is overactive (Hyperthyroidism)

-    if you are taking monoamine oxidase inhibitors or if you are taking tricyclic antidepressants

(for depression) or have taken them within the last 14 days

-    if you suffer from severe liver disease (severe hepatic insufficiency)

-    if you suffer from acute inflammation of the liver (acute hepatitis).

-    if you suffer from alcohol abuse

Warnings and precautions

Talk to your doctor before taking ratiopharm Cold & Flu Lemon Flavour

-    if you have Raynaud’s Phenomenon, a condition caused by poor blood-circulation in the fingers and toes.

-    if you have Diabetes mellitus, a condition associated with high levels of blood-sugar.

-    if you    suffer from moderate and severe renal    insufficiency.

-    if you    suffer from liver function disorders:

mild to moderate hepatocellular insufficiency (including Gilbert’s syndrome), concomitant treatment with medicinal products affecting hepatic functions.

-    if you suffer from haemolytic anaemia (a reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness).

-    if you    suffer from dehydration.

-    if you    suffer from chronic malnutrition.

-    if you    suffer from glutathione depletion due to    metabolic    deficiencies.

-    if your prostate is enlarged

-    if you suffer from a neuroendocrine tumor of the medulla of the adrenal glands (pheochromocytoma)

-    if you have asthma and are hypersensitive to acetylsalicylicacid (for pain relief or for blood-dilution). You may also be hypersensitive to Paracetamol/Phenylephrine.

Important:

This product contains Paracetamol. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Do not take with any other flu, cold or decongestant products.

Children and adolescents

ratiopharm Cold & Flu Lemon Flavour is indicated for adults and children over 16 years of age.

Other medicines and ratiopharm Cold & Flu Lemon Flavour

Do not use ratiopharm Cold & Flu Lemon Flavour if you are taking monoamine oxidase inhibitors (MAO inhibitors, such as moclobemide or tranylcypromin) or tricyclic antidepressants (such as amitriptyline, amoxapine, clomipramine, desipramine and doxepine), used for treatment of depression, or have taken them within the last 14 days.

Do not combine decongestant nose drops, containing phenylephrine and ephedrine or other sympathomimetics with ratiopharm Cold & Flu Lemon Flavour.

As both of the active substances of ratiopharm Cold & Flu Lemon Flavour, phenylephrine hydrochloride and paracetamol, may adversely interact with other medicines, please make sure that you tell your doctor or pharmacist about all other medicines you might be using at the same time, especially:

-    Drugs, which may interfere with phenylephrine as medicines used for the treatment of high blood pressure, heart or circulatory problems as

-    sympathomimetics

-    vasodilators

-    beta-blockers and other antihypertensives

-    Drugs, which may potentiate the effect of phenylephrine on the blood vessels, as

-    digoxin (for heart diseases)

-    tetracyclics (for depression) such as maprotiline

-    antidepressants such as phenelzine, isocarboxylic acid, nialamide

-    Parkinson's disease drugs such as selegiline

-    furazolidone (for bacterial infections)

-    Drugs, which may interfere with the liver-metabolism of the active substances of ratiopharm Cold & Flu Lemon Flavour and may increase the toxic effects of paracetamol on the liver, as

-    alcohol

-    barbiturates (sedatives),

-    anticonvulsants (for epilepsy) such as phenytoin, phenobarbital, methylphenobarbital and primidone

-    rifampicin (for tuberculosis)

-    probenecid (for gout)

-    Drugs, which have an influence of the availability of paracetamol in the body, as

-    anticholinergic drugs (e.g. glycopyrronium, propantheline)

-    metoclopramide or domperidone (for feeling sick or being sick)

-    cholestyramine (to reduce blood fat levels)

-    isoniazide (for tuberculosis)

-    propranolol (for high blood pressure)

-    warfarin and other coumarins (blood thinners), as their anticoagulant effect may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses of ratiopharm Cold & Flu Lemon Flavour have no significant effect.

-    Regular use of paracetamol may increase the toxic effects of zidovudine (AZT) (for treatment for HIV)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

ratiopharm Cold & Flu Lemon Flavour with alcohol

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking ratiopharm Cold & Flu Lemon Flavour.

Pregnancy and breast-feeding

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.

ratiopharm Cold & Flu Lemon Flavour is not recommended during pregnancy and breastfeeding. Driving and using machines

There have been no reports on negative influence of ratiopharm Cold & Flu Lemon Flavour on the ability to drive and to use machines up to date.

ratiopharm Cold & Flu Lemon Flavour contains sucrose, aspartame, sorbitol, carbohydrates

This medicine contains aspartame (E951) which is a source of phenylalanine. May be harmful for people with phenylketonuria (a hereditary metabolic-disorder).

The medicine contains sorbitol (E420) and 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.

Each sachet contains approximately 1.9 g of carbohydrates. This should be taken into account in patients with diabetes mellitus.

3. How to take ratiopharm Cold & Flu Lemon Flavour

Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist, if you are not sure.

The recommended dose is:

Age

How many

How often

Adults and children over 16 years of age

One sachet

The dose may be repeated in 4 to 6 hours.

Do not take more than 4

sachets in 24 hours.

Method of administration

Oral administration after dissolution in water.

Dissolve the contents of the sachet in a small cup (125 ml) of hot, but not boiling, water. Stir shortly until dissolved and drink the fruity and coulorless solution.

This medicine is for short-term use only. Do not take this medicine for more than 3 days without talking to your doctor.

Use in children and adolescents

ratiopharm Cold & Flu Lemon Flavour is not recommended for use in children and adolescents below 16 years of age.

Elderly

There is no indication that the dosage needs to be modified in the elderly.

If you take more ratiopharm Cold & Flu Lemon Flavour than you should

If you or someone else took too much of ratiopharm Cold & Flu Lemon Flavour, or if you think a child has swallowed any of content of the sachets, contact your nearest hospital casualty department or your doctor immediately, even if you/the other person feel/feels well, because of the risk of delayed, serious liver damage. Please take this leaflet, any remaining sachets and the container with you to the hospital or doctor so that they know which medicinal product was consumed.

If you forget to take ratiopharm Cold & Flu Lemon Flavour

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.

Most people will not have problems, but some may get some.

The following summary includes side effects of paracetamol and phenylephrine. Within each

frequency grouping, undesirable effects are presented in order of decreasing seriousness

Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the available data

Paracetamol

In therapeutic doses, the undesirable effects of paracetamol occur rarely and with mild clinical course. Rare:

Blood and lymphatic system disorders: blood disorders which may be seen as unexplained bruising, paleness or poor resistance to infections: Blood dyscrasias including platelet disorders, reduction of specific blood-cells (agranulocytosis, leucopenia, thrombocytopenia), haemolytic anaemia, pancytopenia.

Hepatobiliary disorders: Abnormal hepatic function (increase in hepatic transaminases), hepatic failure, hepatic necrosis, jaundice (yellowing of the skin or eyes).

Skin and subcutaneous tissue disorders: Hypersensitivity including skin rash and urticaria, pruritus, sweating, purpura (small bleedings underneath the skin), angioedema (sudden swelling of the skin an mucous membrane).

Immune system disorders: Allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis (serious allergic reaction which causes difficulty in breathing or dizziness).

Very rare:

Respiratory, thoracic and mediastinal disorders: bronchospasm (difficulty in breathing or wheezing)

Renal and urinary disorders: After prolonged use of high doses of paracetamol sterile pyuria (urine which contains white blood cells, cloudy urine) and renal side effects may develop

Gastrointestinal disorders: Acute pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen or back)

Phenylephrine

Common:

Gastrointestinal disorders: Loss of appetite, nausea and vomiting

Rare:

Cardiac disorders: Tachycardia (faster heart beat), palpitation (feeling your heartbeat)

Vascular disorders: blood pressure increase

Immune system disorders: Allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis (serious allergic reaction which causes difficulty in breathing or dizziness) and bronchospasm (difficulty in breathing or wheezing)

Very rare:

Nervous system disorders: Insomnia (difficulty in sleeping), nervousness, tremor (shaking), anxiety, restlessness, confusion, irritability, dizziness and headache may occur

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE RATIOPHARM COLD & FLU LEMON FLAVOUR

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 and sachet. The expiry date refers to the last day of that month.

Duration of storage after reconstitution:

The reconstituted solution in hot water is stable for 60 min at room temperature.

Store in original container in order to protect from light and moisture.

This medicinal product does not require any special temperature storage conditions.

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. Content of the pack and other information

What ratiopharm Cold & Flu Lemon Flavour contains

-    The active substances are: Paracetamol 500 mg and Phenylephrine hydrochloride 12.2 mg (equivalent to phenylephrine base 10.0 mg)

-    The other ingredients are: Ascorbic acid, Sucrose, Aspartame (E951), Lemon flavour (Lemon flavour contains: Natural lemon oils and natural and nature identical flavouring substances, Maltodextrin, Mannitol (E421), Gluconolactone, Acacia , Sorbitol (E420) and Silica colloidal anhydrous and all-rac-alpha-Tocopherol (E 307)), Saccharin sodium, Silica colloidal anhydrous, Citric acid anhydrous, and Sodium citrate.

What ratiopharm Cold & Flu Lemon Flavour looks like and contents of the pack

ratiopharm Cold & Flu Lemon Flavour is a white coloured powder which is packed in laminated

sachets in a carton box.

Pack-sizes:

6, 8, 10, 12, 14, 16, 20 sachets are contained in a cardboard carton.

Marketing Authorisation Holder

ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany Manufacturer

Hermes Pharma Ges.m.b.H, Allgau 36, 9400 Wolfsberg, Austria OR*

Merckle GmbH, Ludwig-Merckle-StraBe 3, 89143 Blaubeuren, Germany OR*

Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands OR*

TEVA Pharma B.V., Swensweg 5, 2031 Haarlem, The Netherlands OR*

TEVA Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary

This leaflet was last revised 06/2012

PL 15773/0912

*Only the actual site of batch release will appear on the printed version of the leaflet