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DROPIZOL 10 MG/ML ORAL DROPS SOLUTION

Active substance(s): OPIUM

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Dropizol 10 mg/ml

oral drops, solution

Morphine in opium tincture

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 or nurse.
– 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,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1. What Dropizol is and what it is used for
2. What you need to know before you take
Dropizol
3. How to take Dropizol
4. Possible side effects
5. How to store Dropizol
6. Contents of the pack and other information

1. What Dropizol is and what it is used
for
Dropizol is an herbal medicinal product that
contains morphine.
Dropizol belongs to a group of medicines called
antipropulsives, and is used in adults to treat
severe diarrhoea such as diarrhoea caused by
cancer medication, radiation or certain tumours.
Dropizol should only be used if other diarrhea-stopping treatments have not given sufficient effect. It works by inhibiting the movements of the intestine.

2. What you need to know before you
take Dropizol
Do not take Dropizol:
• If you are allergic to opium or morphine or
any of the other ingredients of this medicine
(listed in section 6)
• If you have opiate dependency
• If you suffer from glaucoma (raised pressure
in the eye)
• If you have severe liver or kidney disease
• If you have alcohol withdrawal symptoms
(delirium tremens).
• If you have a severe head trauma
• If you are at risk of paralytic ileus (obstruction
of the intestine due to paralysis of the intestinal muscles)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Dropizol:
• If you are elderly, as elderly people may react
differently to this medicine. The dose may
need to be adjusted.
• If you suffer from acute asthma, COPD (a
chronic pulmonary disease that makes it hard
to breathe) or other respiratory diseases, or
you have difficulty breathing
• If you have a chronic kidney and/or liver
disease. The dose may need to be adjusted.
• If you are addicted to narcotics or alcohol
• If you have gallbladder disease or gallstones
• If you have a head injury or increased pressure in the brain
• If you have reduced consciousness
• If you have heart failure secondary to lung
disease
• If you have severe heart and lung disorder
• If you are taking medication for depression
(moclobemide or other MAO-inhibitors) or
have stopped using this medication within the
last 2 weeks
• If you have reduced adrenal glands function
• If you have underactive thyroid, the dose may
need to be adjusted.
• Low blood pressure with decreased blood
volume
• Infection of the pancreas
• If you have prostatic hyperplasia (enlargement of the prostate) and/or conditions
predisposing to urinary retention.
• If you have an infection or inflammation of
the intestines since inhibition of peristalsis
may increase the risk of uptake of toxins and
development of an enlarged colon and perforation of your intestines.
• If you suffer from epilepsy
If you experience difficulty to urinate a health
care professional should be contacted.
Dropizol is not recommended before surgery
or within 24 hours after operation due to risk
of paralytic ileus. The symptoms of which are
nausea and vomiting.

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Risk for dependence and tolerance when using
the product.
Children and adolescents
Dropizol should not be used in children and
adolescents aged below 18 years.
Other medicines and Dropizol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
It is especially important that you tell your
doctor or pharmacist if you are taking:
• Medicines that potentiate the reduced
consciousness and difficulty breathing, seen
with Dropizol, such as
– Alcohol
– Sleeping medicines and general anesthetics (e.g. barbiturates)
– Medicines to treat depression or
Parkinson’s disease (MAO-inhibitors)
– Antipsychotic medicines with a sedative
action (e.g. fentiazines)
– Medicines to treat epilepsy (gabapentin)
– Medicines to relieve nausea and vomiting
– Medicines to relieve allergy (antihistamines)
– Other opioid pain relievers
• Medicines that have a similar mode of action
as morphine and therefore may increase withdrawal symptioms and reduce therapeutic
effect (buprenorphine, nalbuphine, pentazocine)
• Medicines to treat alcohol abuse (disulfiram)
or medicines to treat certain kinds of infections (metronidazole) as this might cause
unpleasant side effects such as flushing,
rapid breathing and fast heart rate
• Medicines used for anaesthesia, trouble
sleeping and to relieve anxiety (midazolam) as
this may increase the respiratory side effects
seen with Dropizol.
• Medicines to treat tuberculosis (rifampicin)
decreases the effect of morphine
• Cimetidine may increase the effect of
morphine
• Zidovudine (medicine to treat or prevent HIV
infections).
• Medicines to treat depression (fluoxetine) might reduce the duration of action of
morphine
Dropizol with food, drink and alcohol
Dropizol can be taken with food and drink.
Dropizol contains alcohol, so extra care should
be exercised when consuming alcohol.
Pregnancy, breast-feeding and fertility
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.
Pregnancy:
Do not take Dropizol during pregnancy unless
your doctor has told you to. Take with caution
in pregnant women. Dropizol should not be
taken in the last trimester due to the risk of
drowsiness and difficulty breathing in the infant
at birth or withdrawal symptoms in the neonate.
Breastfeeding:
Dropizol should not be used during breastfeeding, as opium passes into human milk.
Fertility:
Fertile men and women should use effective
contraception when using Dropizol.
Driving and using machines
Dropizol contains morphine and ethanol and it
may cause drowsiness and significantly affect
your ability to drive or operate machines.
Do not drive after taking your medicines until
you know how they affect you
Dropizol contains ethanol
This medicinal product contains 33 V/V %
ethanol (alcohol), i.e. up to 330 mg per dose,
equivalent to 6.6 ml of beer or 2.8 ml of wine
per dose. Harmful for those suffering from
alcoholism. To be taken into account in pregnant
or breast-feeding women, children and high-risk
groups such as patients with liver disease, or
epilepsy.

3. How to take Dropizol
Always take this medicine exactly as your doctor
told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose is:
Adults: 5 – 10 drops 2 – 3 times daily.

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Package leaflet: Information for the patient

Single dose should not exceed 1 ml and the total
daily dose should not exceed 6 ml.
Elderly: The dosage should be reduced initially.
Hepatic impairment: Dropizol should not be used
or the dosage should be reduced. Please see
section 2 “Do not take” and section 2 “Warnings
and precautions”.
Renal impairment: Dropizol should not be used
or the dosage should be reduced.
Please see section 2 “Do not take” and section 2
“Warnings and precautions”.
There is about 19 drops in 1 ml.
Method of administration:
Oral use.
Dropizol can be used undiluted or mixed in a
glass of water. After mixture with water, it
should be used immediately. If Dropizol is used
undiluted the correct dosage can be administered with a spoon.
Use in children and adolescents
Dropizol should not be used in children and
adolescents below 18 years.
If you take more Dropizol than you should
If you take too much Dropizol you may experience breathing difficulties and depressed levels
of consciousness which may lead to coma. Call
your doctor if you have taken more Dropizol than
your doctor has prescribed for you or as stated
in this leaflet and you feel uncomfortable.
If you forget to take Dropizol
You should take the missed dose as soon as you
remember, unless it is nearly time for the next
dose. Do not take a double dose to make up for
a forgotten dose.
If you stop taking Dropizol
Continue the medicine as long as your doctor
has told you so.

Not known (frequency cannot be estimated
from the available data):
Euphoria (strong sense of well-being, happiness and excitement), cardiac arrhythmia (fast
or slow heartbeat) and uncontrolled muscle
movements
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.
You can also report side effects directly via
Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or Apple
App Store.
By reporting side affects you can help provide
more information on the safety of this medicine.

5. How to store Dropizol
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 bottle. The
expiry date refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
After first opening, the bottle may be used for
4 weeks.
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 Dropizol contains
– The active substance is: Opium tincture

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

1 ml of oral liquid contains 1 ml of tincture
from Papaver somniferum L., succus siccum
(Opium, raw) corresponding to 10 mg of
morphine.

4. Possible side effects

1 drop contains 50 mg opium tincture equivalent to 0.5 mg (10 mg/ml) anhydrous morphine.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects
Uncommon (may affect up to 1 in 100 people):
Shortness of breath and difficulty breathing.
Other side effects
Very common (may affect more than 1 in 10
people):
Drowsiness and constipation, dry mouth
Common (may affect up to 1 in 10 people):
Dizziness, pupil contraction, nausea and
vomiting, difficulty urinating, bronchospasm,
decreased coughing, asthenia
Uncommon (may affect up to 1 in 100 people):
Itching, spasms in the lower urinary tract,
abnormal liver tests
Rare (may affect up to 1 in 1,000 people):
Orthostatic hypotension (a form of low blood
pressure that happens when you stand up from
sitting or lying down)

1 ml contains 19 drops.
– Extraction solvent: 33 % ethanol (V/V)
What Dropizol looks like and contents of the
pack
Dropizol is a dark, reddish brown liquid. It is
available in a brown glass bottle with dropper
and a child-proof locker.
Pack sizes 1 x 10 ml, 3 x 10 ml and 10 x 10 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pharmanovia A/S
Jægersborg Allé 164
DK-2820 Gentofte
Denmark
e-mail: info@pharmanovia.com
Manufacturer
Lomapharm – Rudolph Lohmann GmbH KG
Langes Feld 5
D-31860 Emmerthal
Germany

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
Sverige
Suomi/Finland
Danmark
Dropium®
Dropizol®
Dropizol®
Pharmanovia A/S
Pharmanovia A/S
Pharmanovia A/S
Jægersborg Allé 164
Jægersborg Allé 164
Jægersborg Allé 164
DK-2820 Gentofte
DK-2820 Gentofte
DK-2820 Gentofte
Danmark
Danmark
Tanska
info@pharmanovia.com
info@pharmanovia.com
info@pharmanovia.com
Ísland
Dropizol®
Pharmanovia A/S
Jægersborg Allé 164
DK-2820 Gentofte
Danmörk
info@pharmanovia.com

Norge
Dropizol®
Pharmanovia A/S
Jægersborg Allé 164
DK-2820 Gentofte
Danmark
info@pharmanovia.com

UK
Dropizol®
Pharmanovia A/S
Jægersborg Allé 164
DK-2820 Gentofte
Denmark
info@pharmanovia.com

This leaflet was last revised in September, 2017.

1709 UK

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Expand Transcript

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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