Package leaflet: Information for the user

Grippostad Day Cold and Flu Relief Capsules Paracetamol, caffeine, phenylephrine hydrochloride

What is in this leaflet

1.    What Grippostad Day Cold and Flu Relief Capsules is and what it is used for

2.    What you need to know before you take Grippostad Day Cold and Flu Relief Capsules

3.    How to take Grippostad Day Cold and Flu Relief Capsules

4.    Possible side effects

5.    How to store Grippostad Day Cold and Flu Relief Capsules

6.    Contents of the pack and other information

Grippostad Day Cold and Flu Relief Capsules contains three drugs to help treat your

symptoms (active ingredients):

•    Paracetamol, which is an analgesic (pain killer) and antipyretic (it reduces body temperature when you have a fever)

•    Phenylephrine, which is a type of drug known as a sympathomimetic. This works as a decongestant by unblocking the passages in and around your nose. This helps you to breathe more easily.

•    Caffeine, which acts to further help the effectiveness of paracetamol.

Grippostad Day Cold and Flu Relief Capsules is used to relieve the symptoms of colds and

influenza (flu) including fever, aches and pains, sore throat and nasal congestion.

This medicine is for use in adults and children aged 12 years and over.

DO NOT take Grippostad Day Cold and Flu Relief Capsules

•    If you are allergic to paracetamol, caffeine, phenylephrine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).

•    If you have a rare hereditary disease known as glucose-6-phosphate dehydrogenase (G6PD) deficiency. G6PD deficiency is a shortage of an enzyme and can lead to anaemia (a shortage of red blood cells).

•    If you have a tumour of the adrenal glands called a phaeochromocytoma. The adrenal glands are triangle-shaped and located on top of your kidneys.

•    If you have severe kidney problems

•    If you have high blood pressure

•    If you have a thyroid gland that is too active

•    If you have diabetes

•    If you have heart disease

•    If you have raised pressure in the eye (glaucoma)

•    If you are taking drugs known as beta blockers

•    If you are taking drugs for depression known as tricyclic antidepressants

•    If you are taking or have taken drugs for depression known as monoamine oxidase inhibitors (MAOIs) in the last two weeks

Warnings and precautions

•    If you have an enlarged prostate gland. Symptoms of an enlarged prostate gland include difficulty urinating, painful urination, or urinating more often.

•    If you have Raynaud's phenomenon (discolouration of the fingers and toes caused by poor circulation)

•    If you have heart or circulation problems

•    If you are dehydrated

•    If you suffer from chronic malnutrition

•    If you have a loss of glutathione due to metabolic deficiencies

•    If you are an alcoholic

You should not use Grippostad Day Cold and Flu Relief Capsules if you are also using other sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

Do not take too much caffeine (e.g. coffee, tea and some canned drinks) when you are taking Grippostad Day Cold and Flu Relief Capsules.

Do not take any other medicines containing paracetamol. Taking too much paracetamol can lead to serious liver damage which can sometimes be fatal. You should take particular care if you have liver or kidney disease. You are more at risk of overdose if you are an alcoholic.

You should see your doctor if:

•    you develop a high fever

•    you develop signs of other infection such as feeling unwell, night sweats, tiredness, pain, or swelling

•    your symptoms do not get better after three days

Other medicines and Grippostad Day Cold and Flu Relief Capsules

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

medicines.

The following medicines may affect or be affected by Grippostad Day Cold and Flu Relief Capsules

You should not take Grippostad Day Cold and Flu Relief Capsules with any of the following medicines without first talking to your doctor:

•    Monoamine oxidase inhibitors (MAOIs), including moclobemide

•    Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma)

•    Beta blockers and other antihypertensive drugs (used to treat high blood pressure), including debrisoquine, guanethidine, reserpine, and methyldopa

•    Tricyclic antidepressants, for example amitriptyline, used to treat feeling sad (depression)

•    Cardiac glycosides (drugs used to control heart rhythms or contractions) for example digoxin

•    Ergot alkaloids (drugs used to treat migraine), for example ergotamine and methysergide

•    Anticoagulants (drugs used to thin the blood, such as warfarin)

•    Propantheline (used to treat gastrointestinal disorders, wetting (enuresis), and excessive sweating (hyperhidrosis)

•    Pethidine and pentazocine (pain killers)

•    Metoclopramide or domperidone (used to treat nausea and vomiting)

•    Colestyramine (used to lower blood cholesterol)

•    Carbamazepine, phenobarbital, phenytoin, and primidone (used to treat epilepsy)

•    Rifampicin (an antibiotic)

•    St John's wort (used to treat depression)

Do not take Grippostad Day Cold and Flu Relief Capsules with other products containing paracetamol.

Grippostad Day Cold and Flu Relief Capsules with drink and alcohol Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.

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.

Do not take this product if you are pregnant or while breast-feeding.

Driving and using machines

Take care when driving. Grippostad Day Cold and Flu Relief Capsules may affect your reactions, especially:

•    at the start of treatment

•    after increasing your dose

•    when changing from a different medication

•    if you also drink alcohol

Do not operate any tools or machines or drive if your reactions are affected.

Important information about some of the ingredients of Grippostad Day Cold and Flu Relief Capsules

•    Warning:

Grippostad Day Cold and Flu Relief Capsules contains paracetamol and a drug to reduce congestion in the nasal passages (decongestant). Do not take with any other product for the relief of flu, colds or nasal congestion, or with other products containing paracetamol.

3. How to take Grippostad Day Cold and Flu Relief Capsules

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:

Adults (including the elderly):

Take 2 capsules up to 4 times a day as required. Do not take more than 8 capsules in 24 hours. Leave at least 4 hours between doses.

Children between 12 and 18 years of age

Take 2 capsules up to 3 times a day as required. Do not take more than 6 capsules in 24 hours. Leave at least 4 hours between doses.

Do not take a higher dose than the recommended dose without first talking to your doctor.

Grippostad Day Cold and Flu Relief Capsules should be used during daytime only, as it contains caffeine, which may cause sleeplessness.

How to take Grippostad Day Cold and Flu Relief Capsules The capsules should be taken by mouth.

Swallow the capsules whole with water. Do not chew.

For how long should you take Grippostad Day Cold and Flu Relief Capsules If your symptoms do not get better after three days, talk to your doctor.

Children under 12 years

Do not give Grippostad Day Cold and Flu Relief Capsules to children under 12 years old.

You are at greater risk of overdose if:

•    you are taking any of the following medicines for more than a few weeks:

o carbamazepine, phenobarbital, phenytoin, and primidone (used to treat epilepsy) o rifampicin (an antibiotic) o St John's wort (used to treat depression)

•    you regularly drink too much alcohol

•    you have a shortage of a protein called glutathione. This can be due to: o an eating disorder such as lack or loss of appetite

o starvation, or if you lose weight even when eating normally (a body wasting disease called cachexia)

o cystic fibrosis (a hereditary disease causing breathing difficulties) o HIV infection (AIDS)

Symptoms of overdose in the first 24 hours are:

•    Pale skin (pallor)

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Lack of appetite (anorexia)

•    Tummy pain (abdominal pain)

Other symptoms are:

•    Problems with breaking down glucose

•    Too much acid in the body (metabolic acidosis).

Severe overdose can be fatal and lead to:

•    Liver failure

•    Brain damage (encephalopathy)

•    Bleeding (haemorrhage)

•    Low blood sugar levels (hypoglycaemia)

•    Swelling of the brain (cerebral oedema)

•    Kidney failure with loin pain (acute tubular necrosis)

•    Blood in the urine (haematuria)

•    Protein in the urine (proteinuria)

•    Irregular heartbeat (cardiac arrhythmia)

•    Inflamed pancreas (pancreatitis)

•    Pain in the upper part of the tummy (epigastric pain)

•    Being sick (vomiting)

•    Increased urine production (diuresis)

•    Rapid heartbeat (tachycardia)

•    Stimulation of the nervous system including: o difficulty sleeping (insomnia)

o restlessness o excitement

o feeling anxious (agitation) o feeling nervous and flustered (jitteriness) o uncontrolled shaking (tremors) o fits (convulsions)

•    Other effects similar to those under section 4 "Possible Side Effects” in this leaflet

•    High blood pressure (hypertension)

•    Slow heartbeat (reflex bradycardia)

•    Confusion

•    Seeing or hearing things that are not there (hallucinations)

If you forget to take Grippostad Day Cold and Flu Relief Capsules Do not take a double dose to make up for a forgotten capsule.

Make sure your next dose is taken at least four hours after your previous dose.

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

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

If you experience any of the following stop using the medicine and seek immediate help

• Allergic reactions:

o swelling of the skin, of the face and lips, tongue and throat, or voice box (angio-oedema)

o difficulty breathing (dyspnoea) o sweating

o feeling sick (nausea)

o low blood pressure (hypotension) leading to shock o severe allergic reaction (anaphylaxis)

If you experience any of the following, stop using the medicine and talk to your doctor

•    Allergic skin reactions (cutaneous hypersensitivity reactions) including: o skin rashes

o Stevens Johnson syndrome (a serious illness with blistering of the skin, mouth, eyes and genitals)

o Toxic Epidermal Necrolysis (severe blistering and peeling of the skin)

•    Allergic reactions, for example: rash, hives (urticaria), skin inflammation (allergic dermatitis)

•    Allergic (hypersensitivity) reactions. If you have had an allergic reaction with other sympathomimetic drugs (such as pseudoephedrine) before, you are more likely to have an allergic reaction (cross-sensitivity)

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

•    Very rare cases of serious skin reactions have been reported

•    Liver problems (hepatic dysfunction)

Not known (frequency cannot be estimated from the available data):

•    Low numbers of blood cells called platelets or thrombocytes (thrombocytopenia)

•    Low numbers of white blood cells called leukocytes (leukopenia)

•    A severe lack of white blood cells (agranulocytosis)

•    Low numbers of red and white blood cells (pancytopenia)

•    Tiredness

•    Headache

•    Dizziness

•    Difficulty sleeping (insomnia)

•    Anxiety

•    Nervousness

•    Feeling irritated (irritability)

•    Restlessness

•    Feeling excited (excitability)

•    Worsening of raised pressure in the eye (pre-existing narrow-angle glaucoma) (see also section 2, "DO NOT take Grippostad Day Cold and Flu Relief Capsules ”)

•    Dilated pupils (mydriasis)

•    Sudden raised pressure in the eye (acute angle closure glaucoma)

•    High blood pressure (hypertension)

•    Feeling your heartbeat (palpitations)

•    Rapid heartbeat (tachycardia)

•    Narrowing of the upper airways (bronchospasm)

•    Dry mouth

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Runny stools (diarrhoea)

•    Lack of appetite (anorexia)

•    Kidney problems (renal dysfunction)

•    Difficulty urinating (dysuria) or inability to urinate (urinary retention). This is more likely to occur if your bladder is blocked, for example if you have an enlarged prostate. See also section 2, "Warnings and precautions.”

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 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.

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

Do not store above 25 °C.

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.

What Grippostad Day Cold and Flu Relief Capsules contains The active substances are:

•    paracetamol

•    caffeine

•    phenylephrine hydrochloride

Each capsule contains:

•    300 mg paracetamol

•    25 mg caffeine

•    5 mg phenylephrine hydrochloride

The other ingredients are:

•    ascorbic acid

•    glycerol tristearate

•    sodium laurylsulphate

•    colloidal anhydrous silica

•    magnesium stearate

The other ingredients in the capsule shell are:

•    gelatin

•    titanium dioxide (E 171)

•    yellow iron oxide (E 172)

What Grippostad Day Cold and Flu Relief Capsules Capsules looks like and contents of the pack

Grippostad Day Cold and Flu Relief Capsules are hard capsules of size 1 with a white body and a yellow cap Filled with white to yellow powder.

Grippostad Day Cold and Flu Relief Capsules are available in:

•    OPA/Alu/PVC-glassine paper/Alu/PVC/PVAC blister strips

Blister strips are packed into cardboard cartons.

Pack sizes are 10, 12, 20 and 24 capsules.

Not all pack sizes are marketed.

Marketing Authorisation Holder STADA Arzneimittel AG

Stadastr. 2-8 61118 Bad Vilbel Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom Spain Ireland Italy Poland Romania

Grippostad Day Cold and Flu Relief Capsules Grippostad paracetamol/cafelna capsulas duras Paralief Cold & Flu hard capsules, Paracetamol 300 mg Caffeine 25 mg Phenylephrine hydrochloride 5 mg Grippostad Grippostad Grippostad Zi capsule

This leaflet was last revised in 02/2016.