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COLDYN MAX STRENGTH 1000 MG /12.2 MG POWDER FOR ORAL SOLUTION

Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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Coldyn Max Strength
1000 mg/ 12.2 mg powder for oral solution, sachet
Each sachet contains Paracetamol 1000 mg and
Phenylephrine Hydrochloride 12.2 mg

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Coldyn Max Strength
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- You must see a doctor if your symptoms worsen or
do not improve after 3 days.
- If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Coldyn Max Strength is and what it is used for
2. Before you take Coldyn Max Strength
3. How to take Coldyn Max Strength
4. Possible side effects
5. How to store Coldyn Max Strength
6. Further information
1. WHAT Coldyn Max Strength IS AND WHAT IT
IS USED FOR
Coldyn Max Strength contains paracetamol, an
analgesic which relieves pain and reduces fever,
and phenylephrine, a decongestant to relieve a
blocked up nose.
Coldyn Max Strength is used for the relief of the
symptoms of colds and influenza, including the relief
of aches and pains, sore throat, headache, nasal
congestion and lowering of temperature.
2. BEFORE YOU TAKE Coldyn Max Strength
Do not take Coldyn Max Strength
- if you are allergic (hypersensitive) to paracetamol,
phenylephrine hydrochloride or any of the other
ingredients of Coldyn Max Strength ;
- if you have severe coronary heart disease;
- 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.
Take special care with Coldyn Max Strength
- 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;
- if you suffer from 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 acetyl
salicylic acid (for pain relief or for blood-dilution).
You may also be hypersensitive to Coldyn Max
Strength .
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.
Please contact your doctor, if your symptoms are

Coldyn Max Strenght 1000mg_UK.indd 1

not relieved or even deteriorated within 3 days of
therapy with Coldyn Max Strength.
Taking other medicines
Do not use Coldyn Max Strength if you are taking
monoamine oxidase inhibitors (MAO inhibitors,
such as moclobemide or tranylcypromin) or tricyclic
antidepressants (such as amitryptiline, 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 Coldyn
Max Strength 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 bloodvessels, 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 Coldyn Max Strength
and may increase the toxic effects of Paracetamol
on the liver, as
- alcohol,
- barbiturates (sedatives),
- anticonvulsants (for epilepsy) such as phenytoine,
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
Coldyn Max Strength have no significant effect.
Regular use of paracetamol may increase the toxic
effects of zidovudine (AZT) (for treatment for HIV).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription,
including herbal and homeopathic remedies.
Taking Coldyn Max Strength with food and drink
Do not drink alcohol (e.g. wine, beer, spirits) whilst
taking Coldyn Max Strength, because alcohol may
increase the toxic effects of paracetamol on your liver.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Coldyn Max Strength is not recommended during
pregnancy and breastfeeding.
Driving and using machines
There have been no reports on negative influence of
Coldyn Max Strength on the ability to drive and to
use machines up to date.
Important information about some of the
ingredients of Coldyn Max Strength
This medicine contains aspartame (E951) which is a
source of phenylalanine. May be harmful for people
with phenylketonuria.
This medicinal products also contains Sorbitol (from
the lemon flavour) 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.
3. HOW TO TAKE Coldyn Max Strength
Dissolve the contents of the sachet in a mug (250 ml
of hot, but not boiling, water).

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Stir until dissolved and drink the lemon flavored and
coulorless solution.
The usual dose is:
Age

How many

How often

Adults and
Adolescents
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 3
sachets in 24
hours.

Please observe that higher doses than those
recommended may result in a risk of very serious
liver damage.
Use in children
Coldyn Max Strength is not recommended for use in
children below 16 years of age without medical advice.
Elderly
There is no indication that the dosage needs to be
modified in the elderly.
If you take more Coldyn Max Strength than you
should
If you or someone else took too much of Coldyn Max
Strength, 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 Coldyn Max Strength
Do not take a double dose to make up for a forgotten
dose.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Coldyn Max Strength 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.
Blood and lymphatic system disorders
Rare: Blood disorders which may be seen as
unexplained bruising, paleness or poor restistance
to infections: blood dyscrasias including platelet
disorders, agranulocytosis, leucopenia, thrombo­
cytopenia, haemolytic anaemia, pancytopenia.
Respiratory, thoracic and mediastinal disorders
Very rare: Bronchospasm (difficulty in breathing or
wheezing).
Hepatobiliary disorders
Rare: Abnormal hepatic function (increase in hepatic
transaminases), hepatic failure, hepatic necrosis,
jaundice (yellowing of the skin or eyes).
Skin and subcutaneous tissue disorders
Rare: Hypersensitivity including skin rash and
urticaria, pruritus, sweating, purpura, angioedema.
Immune system disorders
Rare: Allergic or hypersensitivity reactions including
skin rashes, urticaria, anaphylaxis (serious allergic
reaction which causes difficulty in breathing or
dizziness) and bronchospasm.
Renal and urinary disorders
Very rare: After prolonged use of high doses of
paracetamol sterile pyuria (urine which contains
white blood cells, cloudy urine) and renal side
effects may develop.

Coldyn Max Strenght 1000mg_UK.indd 2

Gastrointestinal disorders
Very rare: Acute pancreatitis (inflammation of the
pancreas which causes severe pain in the abdomen
or back).
Phenylephrine
Nervous system disorders
Very rare: Insomnia (difficulty in sleeping),
nervousness, tremor (shaking), anxiety, restless­ness,
confusion, irritability, dizziness and headache may
occur.
Cardiac disorders
Rare: Tachycardia (faster heart beat), palpitation
(feeling your heartbeat).
Vascular disorders
Very rare: Blood pressure increase.
Gastrointestinal disorders
Common: Loss of appetite, nausea and vomiting.
Immune system disorders
Rare: 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).
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.
5. HOW TO STORE Coldyn Max Strength
Keep out of the reach and sight of children.
Do not use Coldyn Max Strength after the expiry
date which is stated on the carton and sachet. The
expiry date refers to the last day of that month.
This medicinal product does not require any special
storage conditions. Store in original package.
The reconstituted solution is stable for 60 min when
stored below 25ºC.
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. FURTHER INFORMATION
What Coldyn Max Strength contains
- 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 (Lemon
flavour contains: natural lemon oils and flavouring
substances, maltodextrin, mannitol, gluconolactone,
acacia gum, sorbitol (E420), α-tocopherol (E307) and
silica, colloidal anhydrous), Saccharin sodium, Silica
colloidal anhydrous, Citric acid, and Sodium citrate.
What Coldyn Max Strength looks like and
contents of the pack
Coldyn Max Strength is a white coloured powder
which is packed in laminated sachets in a carton box.
The product is available in cartons of 10 sachets.
Marketing
Authorisation
Holder
and
Manufacturer
ALKALOID – INT d.o.o.
Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
Tel.: 386 1 300 42 90
Fax: 386 1 300 42 91
e-mail:info@alkaloid.si
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Bulgaria

Caffetin COLDmax 1000 mg/ 12.2 mg
powder for oral solution

Romania

Caffetin COLDmax 1000 mg/ 12.2 mg
pulbere pentru soluţie orală, plic

Slovenia

Coldvin 1000 mg/ 12.2 mg prašek za
peroralno raztopino

United
Kingdom

Coldyn Max Strength 1000 mg/ 12.2 mg
Powder for Oral Solution

PL 34088/0018
Leaflet last revised 10/2011.

1.11.2011 13:13:16

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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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