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GRIPPOSTAD DAY COLD AND FLU RELIEF CAPSULES

Active substance(s): CAFFEINE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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Package leaflet: Information for the user
Grippostad Day Cold and Flu Relief Capsules
Paracetamol, caffeine, 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, 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 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

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

2. What you need to know before you take Grippostad Day Cold and Flu Relief Capsules
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.
If you take more Grippostad Day Cold and Flu Relief Capsules than you should
Contact your doctor or nearest emergency department immediately for advice if:
 You accidentally take too many capsules
 A child under 12 years of age takes any Grippostad Day Cold and Flu Relief Capsules
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 your medicine and this leaflet with you so that the medical staff know what you have
taken.
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.

4. Possible side effects
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.

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

6. Contents of the pack and other information
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/cafeína cápsulas 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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