Sandoz Ltd    Page 1

Paracetamol/Phenylephrine Hydrochloride 500    11/08/2014

mg/12.2 mg &1000 mg/12.2 mg Powder for Oral

Solution

Package leaflet: Information for the patient

Paracetamol/Phenylephrine Hydrochloride 500 mg/12.2 mg Powder for Oral Solution Paracetamol/Phenylephrine Hydrochloride 1000 mg/12.2 mg 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.

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. 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 Paracetamol/Phenylephrine is and what it is used for

2.    What you need to know before you take Paracetamol/Phenylephrine

3.    How to take Paracetamol/Phenylephrine

4.    Possible side effects

5.    How to store Paracetamol/Phenylephrine

6.    Contents of the pack and other information

1. What Paracetamol/Phenylephrine is and what it is used for

Paracetamol/Phenylephrine contains paracetamol, an analgesic which relieves aches and reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose.

Paracetamol/Phenylephrine is used for the relief of the symptoms of colds and influenza, including the relief of pain, headache, nasal congestion and lowering of temperature at adults and adolescents over 16 years of age who weigh more than 50 kg.

Use Paracetamol/Phenylephrine only if you have colds and influenza accompanied by stuffy nose. If you do not have stuffy nose, monocomponent products containing only paracetamol should be preferred.

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

Sandoz Ltd

Paracetamol/Phenylephrine Hydrochloride 500 mg/12.2 mg &1000 mg/12.2 mg Powder for Oral Solution_

2. What you need to know before you take Paracetamol/Phenylephrine Do not take Paracetamol/Phenylephrine:

•    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 or pharmacist before taking Paracetamol/Phenylephrine

•    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), severe hepatic insufficiency (Child-Pugh >9), acute hepatitis and 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.

•    alcohol abuse

•    if you suffer from chronic malnutrition.

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

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

•    If you have an enlarged prostate

•    If you have a tumour on the adrenal gland (called phaechromocytoma)

Important:

This product contains Paracetamol. Do not take with any other paracetamol-containing products. Never take more Paracetamol/Phenylehrine than recommended. Higher doses than those recommended do not increase the pain-relieving effect, but may cause very serious liver damage. The symptoms of liver damage normally do not appear until after a few days. After

an overdose, it is therefore very important to seek medical advice as soon as possible, even if you feel well. Do not take with any other flu, cold or decongestant products.

Children and adolescents

Paracetamol/Phenylephrine is indicated for adults and children over 16 years of age who weigh more than 50 kg.

Other medicines and Paracetamol/Phenylephrine

Do not use Paracetamol/Phenylephrine 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.

As both of the active substances of Paracetamol/Phenylephrine, 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, including nasal or eye decongestant products

-    vasodilators

-    alpha- and beta-blockers and other antihypertensives (e.g. guanethidine)

•    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 Paracetamol/Phenylephrine 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)

Sandoz Ltd

Paracetamol/Phenylephrine Hydrochloride 500 mg/12.2 mg &1000 mg/12.2 mg Powder for Oral Solution_

-    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 Paracetamol/Phenylephrine have no significant effect.

•    regular use of paracetamol may increase the toxic effects of zidovudine (AZT) (for treatment for HIV)

•    the duration of action of chloramphenicol may be prolonged by paracetamol

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

Paracetamol/Phenylephrine with food, drink and alcohol

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking <Paracetamol/Phenylephrine>.

The effect of alcohol will not be enhanced by the addition of paracetamol, but alcohol may increase the toxic effects of paracetamol on your liver.

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. Paracetamol/Phenylephrine is not recommended during pregnancy and breastfeeding.

Driving and using machines

There have been no reports on negative influence of Paracetamol/Phenylephrine on the ability to drive and to use machines up to date.

Paracetamol/Phenylephrine 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.

For 500 mg/12.2 mg:

Each sachet contains 1.8 g of sucrose. This should be taken into account in patients with diabetes mellitus.

For 1000 mg/12.2 mg:

Each sachet contains 3.9 g of sucrose. This should be taken into account in patients with diabetes mellitus.

3. How to take Paracetamol/Phenylephrine

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

The recommended dose is:

Age	How many	How often
Adults and children over 16 years of age Adults and children over 16 years of age who weigh more than 50 kg	One sachet	The dose may be repeated in 4 to 6 hours. Do not take more than 4 sachets in 24 hours.

Please observe that higher doses than those recommended may result in a risk of very serious liver damage.

Method of administration

Oral administration after dissolution in water.

For 500 mg/12.2 mg:

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 lemon-flavoured and coulorless solution.

For 1000 mg/12.2 mg:

Dissolve the contents of the sachet in a mug (250 ml) of hot, but not boiling, water. Stir shortly until dissolved and drink the lemon-flavoured and coulorless solution.

Use in children and adolescents

Paracetamol/Phenylephrine is not recommended for use in children and adolescents below 16 years of age.

Older people

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

If symptoms persist for more than 3 days or worsen, consult your doctor.

If you take more Paracetamol/Phenylephrine than you should

If you or someone else took too much of Paracetamol/Phenylephrine, or if you think a child has swallowed any of content of the sachets, contact your nearest hospital casualty department

Sandoz Ltd    Page 6

Paracetamol/Phenylephrine Hydrochloride 500    11/08/2014

mg/12.2 mg &1000 mg/12.2 mg Powder for Oral

Solution_

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 Paracetamol/Phenylephrine

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.

Paracetamol

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

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

•    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.

•    abnormal hepatic function (increase in hepatic transaminases)

•    hepatic failure

•    hepatic necrosis

•    jaundice (yellowing of the skin or eyes)

•    bronchospasm (difficulty in breathing or wheezing)

•    hypersensitivity including skin rash and urticaria, pruritus, sweating, purpura (small bleedings underneath the skin), angioedema (sudden swelling of the skin an mucous membrane)

•    allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis (serious allergic reaction which causes difficulty in breathing or dizziness).

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

Sandoz Ltd    Page 7

Paracetamol/Phenylephrine Hydrochloride 500    11/08/2014

mg/12.2 mg &1000 mg/12.2 mg Powder for Oral

Solution_

•    after prolonged use of high doses of paracetamol sterile pyuria (urine which contains white blood cells, cloudy urine) and renal side effects may develop

•    acute pancreatitis (inflammation of the pancreas which causes severe pain in the abdomen or back)

Very rare cases of serious skin reactions have been reported.

Phenylephrine

Common (may affect up to 1 in 10 people):

•    loss of appetite

•    nausea and vomiting

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

•    tachycardia (faster heart beat)

•    palpitation (feeling your heartbeat)

•    blood pressure increase

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

•    insomnia (difficulty in sleeping)

•    nervousness

•    tremor (shaking)

•    anxiety

•    restlessness

•    confusion

•    irritability

•    dizziness

•    headache

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 the Yellow Card Scheme: 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/Phenylephrine

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.

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

This medicinal product does not require any special temperature storage conditions

Shelf life after reconstitution:

Reconstituted solution in hot water: 1 hour

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 protect the environment.

6. Content of the pack and other information

What Paracetamol/Phenylephrine contains

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

-    The active substances are Paracetamol 1000 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 (containing: natural lemon oils and nature identical flavouring substances, maltodextrin, mannitol (E421), gluconolactone, acacia gum, sorbitol (E420) , silica colloidal anhydrous, and a - tocopherol (E307)), saccharin sodium, silica colloidal anhydrous, citric acid, and sodium citrate.

What Paracetamol/Phenylephrine looks like and contents of the pack

Paracetamol/Phenylephrine is a free flowing, white powder with lemon odour which is packed in laminated aluminium paper foil sachets in a carton box.

500 mg/12.2 mg:

Pack-sizes: 6, 10, 20 sachets.

1000 mg/12.2 mg:

10 sachets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Limited Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR United Kingdom

Manufacturer

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

Or

Salutas Pharma GmbH Otto-von-Guericke-Allee 1,

Sachsen-Anhalt, 39179 Barleben Germany

This leaflet was last revised in August 2014

PIL. 1391 -2.001 d Licence Application KP